1. Black & Decker Recalls Cordless Electric Lawnmowers Due to Laceration Hazard http://www.cpsc.gov/cpscpub/prerel/prhtml10/10356.html
2. "S T U F F" and Paw Wall Hooks Recalled By Midwest-CBK Due to Violation of Lead Paint Standard http://www.cpsc.gov/cpscpub/prerel/prhtml10/10357.html
3. Deaths Prompt CPSC, FDA Warning on Infant Sleep Positioners http://www.cpsc.gov/cpscpub/prerel/prhtml10/10358.html
4. CPSC Public Calendar
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1. NEWS from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs
Washington, DC 20207
FOR IMMEDIATE RELEASE
September 29, 2010
Release #10-356
Firm's Recall Hotline: (866) 229-5570
Sears Recall Hotline: (888) 281-5314
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7058
Black & Decker Recalls Cordless Electric Lawnmowers Due to Laceration Hazard
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.
Name of Product: Black & Decker and Craftsman brand cordless electric lawnmowers
Units: About 160,000 (these lawnmowers were previously recalled in September 2002 for a fire hazard, and that recall was expanded in August 2006)
Manufacturer: Black & Decker (U.S.) Inc., of Towson, Md.
Hazard: The lawnmower's motor and blade can unexpectedly turn on after the mower's safety key is removed, posing a laceration hazard to consumers. Removing the safety key is designed to keep this from occurring.
Incidents/Injuries: Black & Decker has received 34 reports of the motor operating after removal of the safety key, including two incidents that resulted in finger lacerations, one requiring stitches.
Description: The recalled cordless electric mowers were sold under both the Black & Decker and Craftsman brand names. The recalled Black & Decker mowers have model number CMM1000 or CMM1000R. All date codes and types are included. The date code and type information are both located on a silver and black label affixed to the rear door of the mower. The Black & Decker mowers have either an orange or green deck with a black motor cover. The Craftsman-brand mowers have model number 900.370520 and include all date codes and types. The model number is located on the silver and black label affixed to the rear door of the mower. The Craftsman-brand mowers have a dark green deck with a black motor cover.
Sold at: Home center, hardware and discount stores and authorized Black & Decker dealers nationwide from September 1995 through December 2006 for about $450. Craftsman-brand mowers were sold at Sears and Orchard Supply Hardware stores nationwide from January 1998 through December 2000 for about $450.
Manufactured in: United States, Canada and Mexico
Remedy: Consumers should stop using the recalled lawnmowers immediately and call Black & Decker or Sears for a free inspection and repair, or a credit towards a new cordless lawnmower. Consumers who had their mowers repaired as a result of the previous recalls should also have their mowers inspected and repaired as part of this recall.
Consumer Contact: For additional information, consumers with Black & Decker mowers should contact Black & Decker toll-free at (866) 229-5570 between 8 a.m. and 5 p.m. ET Monday through Friday or visit the firm's website at www.blackanddecker.com. Consumers with Craftsman-brand mowers should call Sears toll-free at (888) 281-5314 between 7 a.m. and 9 p.m. CT Monday through Saturday or visit the firm's website at www.sears.com
To see this recall on CPSC's web site, including pictures of the recalled products, please go to:
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10356.html
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2. NEWS from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs
Washington, DC 20207
FOR IMMEDIATE RELEASE
September 29, 2010
Release #10-357 Firm's Recall Hotline: (800) 422-5583
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
"S T U F F" and Paw Wall Hooks Recalled By Midwest-CBK Due to Violation of Lead Paint Standard
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.
Name of Product: "S T U F F" and Paw Wall Hooks
Units: 4,450
Importer: Midwest-CBK, Inc., of Union City, Tenn.
Hazard: Paint on the metal hooks and on the blue paw hook contains excessive levels of lead, violating the federal lead paint standard.
Incidents/Injuries: None reported.
Description: The wall hook sets were sold in three models: model numbers 74641 and 74642, constructed of five separate wooden letters spelling out the word "S T U F F" and model number 65262 consisting of four separate, different colored wooden paws. Model number 74641 has a Purple S, a Red T, an Orange U, a Green F and a Pink F. Model number 74642 has an Olive S, a Blue T, a Yellow U, a White-striped F, and a Blue F. Attached to each letter is a painted metal coat hook with a painted wooden ball at the end. Each letter is approximately 4 inches long, 3/4 inches wide and 9 ¾ inches tall. Model number 65262 has four separate paw-shaped wooden pieces of different colors -- red, blue, green and pink. Attached to each paw is a wooden peg with a wooden ball at the end. The "S T U F F" wall hook sets have a label on the back of the letter "S" that includes the models 74641 or 74642. The Paw wall hook sets have the model number 65262 on the outside of the box.
Sold at: Gift stores, drug stores, furniture stores, décor outlets and variety stores nationwide from December 2008 through August 2010 for between $10 and $30.
Manufactured in: China
Remedy: The wall hook set should be returned to Midwest-CBK for a full refund. Contact Midwest-CBK at the number provided below to receive a prepaid shipping label and merchandise credit.
Consumer Contact: For additional information, contact Midwest-CBK toll-free at (800) 422-5583 between 7:30 a.m. and 5 p.m. CT, Monday through Friday.
To see this recall on CPSC's web site, including pictures of the recalled products, please go to:
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10357.html
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3. NEWS from CPSC and FDA
U.S. Consumer Product Safety Commission www.cpsc.gov
U.S. Food and Drug Administration www.fda.gov
FOR IMMEDIATE RELEASE
September 29, 2010
Release #10-358
CPSC Hotline: (800) 638-2772
FDA Hotline: 888-INFO-FDA
CPSC Media Contact: (301) 504-7908
FDA's Media Contact: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Deaths prompt CPSC, FDA warning on infant sleep positioners
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA) today warned consumers to stop using infant sleep positioners. Over the past 13 years, CPSC and the FDA have received 12 reports of infants between the ages of 1 month and 4 four months who died when they suffocated in sleep positioners or became trapped and suffocated between a sleep positioner and the side of a crib or bassinet.
Most of the infants suffocated after rolling from a side to stomach position. In addition to the reported deaths, CPSC has received dozens of reports of infants who were placed on their backs or sides in sleep positioners, only to be found later in potentially hazardous positions within or next to the sleep positioners.
"The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern to CPSC," said CPSC Chairman Inez Tenenbaum. "We urge parents and caregivers to take our warning seriously and stop using these sleep positioners, so that children can have a safer sleep."
The two main types of infant sleep positioners are flat mats with side bolsters or inclined (wedge) mats with side bolsters.
Both types of sleep positioners typically claim to help keep infants on their backs and reduce the risk of Sudden Infant Death Syndrome (SIDS). The FDA has never cleared an infant sleep positioner to prevent or reduce the risk of SIDS. In addition, CPSC and the FDA are unaware of any scientific studies demonstrating that infant positioners prevent SIDS or are proven to prevent suffocation or other life-threatening harm.
"To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS," said Dr. Joshua Sharfstein, FDA Principal Deputy Commissioner and a pediatrician. "We want to make sure parents, health care professionals, and childcare providers understand the potential risk of suffocation and stop using infant sleep positioners."
Sleep positioners also typically claim to do one or all of the following: aid in food digestion to ease colic or the symptoms of gastroesophageal reflux disease (GERD); and prevent flat head syndrome (plagiocephaly). In light of the new safety data, FDA believes any benefit from using these devices to ease GERD or prevent plagiocephaly is outweighed by the risk of suffocation.
CPSC and the FDA are warning parents and child care providers to:
STOP using sleep positioners. Using a positioner to hold an infant on his or her back or side for sleep is dangerous and unnecessary.
NEVER put pillows, infant sleep positioners, comforters, or quilts under a baby or in a crib.
ALWAYS place an infant on his or her back at night and during nap time. To reduce the risk of SIDS, the American Academy of Pediatrics recommends placing infants to sleep on their backs and not their sides.
The American Academy of Pediatrics does not support the use of any sleep positioner to prevent SIDS.
Manufacturers of infant sleep positioners with medical claims that have not been reviewed by the FDA should stop marketing those products until they submit, and the FDA clears, appropriate premarket review submissions, including necessary safety and effectiveness data.
FDA has informed manufacturers of cleared devices of the agency's serious concern and has requested that they submit clinical data showing the benefits of their products outweigh the risk of suffocation or other serious harm.
Prompt reporting of adverse events can help the FDA and CPSC identify and better understand the risks associated with infant sleep positioners. If you have had a problem with an infant sleep positioner, the agencies encourage you to file a report through FDA's MedWatch program, at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm
CPSC is interested in receiving incident or injury reports related to these products. Please visit https://www.cpsc.gov/cgibin/incident.aspx to file a report.
For more information:
CPSC: Consumer Blog http://www.cpsc.gov/onsafety/2010/09/sleep-positioners-a-suffocation-risk/
FDA: Infant Sleep Positioners Pose Suffocation Risk (Consumer article) http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm227575.htm
FDA: Infant Positioner Initial Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm227301.htm
FDA: Letter to Manufacturers Concerning Medical Claims About Infant Sleep Positioners http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm227302.htm
FDA: Letter to Manufacturers of 510(k)-cleared Infant Positioners http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm227303.htm
NIH: Back to Sleep Campaign http://www.nichd.nih.gov/publications/pubs/safe_sleep_gen.cfm
NIH: Preventing Sudden Infant Death Syndrome and Suffocation www.nichd.nih.gov/health/topics/Sudden_Infant_Death_Syndrome.cfm
AAP: Policy Statement on SIDS http://aappolicy.aappublications.org/cgi/content/full/pediatrics;116/5/1245
About CPSC
The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of injury or death associated with the use of the thousands of types of consumer products under the agency's jurisdiction. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $800 billion annually. The CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard. CPSC's work to ensure the safety of consumer products-such as toys, cribs, power tools, cigarette lighters, and household chemicals-contributed to a significant decline in the rate of deaths and injuries associated with consumer products over the past 30 years.
To report a dangerous product or a product-related injury, call CPSC's Hotline at (800) 638-2772, teletypewriter at 800-638-8270, or visit www.cpsc.gov/talk.html. Consumers can obtain this press release and recall information at www.cpsc.gov.
About FDA
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and quality of human and veterinary drugs, biological products, medical devices, the nation's food supply, cosmetics, and products that emit radiation. The agency works to advance public health through initiatives that drive innovation in drug, medical device, and food science. The FDA is committed to providing accurate, science-based information to the public on the products it regulates. For more information, visit www.fda.gov
Visit FDA on Facebook http://www.facebook.com/FDA
To see this release on CPSC's web site, including pictures of the products involved and the hazard, please go to: http://www.cpsc.gov/cpscpub/prerel/prhtml10/10358.html
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4. CPSC Public Calendar
Vol. XXXVII No. 51
September 29, 2010
U.S. Consumer Product Safety Commission
Bethesda, Maryland 20814
Commission Agendas
Listed below are agendas of Commission Meetings scheduled for the week of October 4, 2010. For a recorded message concerning the latest agenda information call (301) 504-7948.
No such meetings scheduled at this time.
Meetings Between Commission Staff and Outside Parties
All meetings listed below are open to the public unless otherwise stated. For information on a specific meeting or to attend a meeting, please call the contact person listed for that meeting.
Abbreviations: we use asterisks (*) to identify meetings for the current week which have not appeared before in the printed Public Calendar. If the meeting involves discussion of a "substantial interest matter," defined by CPSC's Meetings Policy, we show the date when we posted notice of the meeting on the Master Calendar. The Master Calendar can be found on CPSC's web site at www.cpsc.gov/calendarmast.html. We indicate whether a meeting is of substantial interest by the symbol (S); we use the symbol (N) to indicate non-substantial interest meetings. The Commission offices are located in the Bethesda Towers Building, 4330 East West Highway, Bethesda, Maryland.
Under the Meetings Policy, a staff person holding or attending a substantial interest meeting must file a log of the meeting with the Office of the Secretary within 20 days.
Week of October 4 thru October 10, 2010
Tuesday, October 5
*Commissioner Robert Adler and Counselors Jana Fong- Swamidoss and Jason Levine meeting with Arlene Blum to discuss the end of life for consumer products treated with halogenated flame retardants; 3:30 p.m., Bethesda Towers, room 723. The meeting was requested by Ms. Blum. For additional information contact Ophelia McCardell, (301) 504- 7731. Transmitted to the Office of the Secretary 9/24/10. Posted on Master Calendar 9/24/10. (S)
Wednesday, October 6
Richard O'Brien, Director of International Programs and Intergovernmental Affairs, will speak on the status of implementation of the Consumer Product Safety Improvement Act at the Product Safety and Liability Conference, focusing on its significance for imported products. The presentation will take place at 1:30 p.m., Radisson, Reagan Airport, Arlington, VA. For more information contact Randal Goodden, (262) 594-5198, info@randallgoodden.com. Transmitted to the Office of the Secretary 9/20/10. Posted on Master Calendar 9/21/10. (N)
Thursday, October 7
Mark Kumagai, Directorate for Engineering Sciences, and other CPSC technical staff meeting with Paul Vitrano, Executive Vice President & General Counsel of the Recreational Off-Highway Vehicle Association (ROHVA and ROHVA members) to discuss an update on ROHVA standards development and safety initiatives; 1:00 - 3:00 p.m., Bethesda Towers, room 410 A/B/C. The meeting was requested by Mr. Paul Vitrano. For additional information contact Mark Kumagai, (301) 504-7532. Transmitted to the Office of the Secretary 8/31/10. Posted on Master Calendar 8/31/10. (S)
Future
Tuesday, October 12
Demar Granados, Office of Compliance and Field Operations, and other CPSC staff meeting with Mr. John Rogers and Dr. John Conkling of the American Fireworks Standards Laboratory (AFSL) Standards Committee to discuss the development of an objective test to determine compliance with 16 C.F.R. § 1500.17(a)(3) and (a)(8); 11:00 a.m., Bethesda Towers, room 834. The meeting was requested by AFSL. For additional information contact Demar Granados, (301) 504-7596. Transmitted to the Office of the Secretary 9/23/10. Posted on Master Calendar 9/23/10. (N)
Thursday, October 14
Kristina Hatlelid, Directorate for Health Sciences, and other staff meeting with Jon Bultemeyer, David Turner, and Wolfgang Schaefer of Marabu GmbH & Co. KG to discuss organic inks; 10:00 a.m., Bethesda Towers, room 715. The meeting was requested by Jon Bultemeyer. For additional information contact Kristina Hatlelid, (301) 504-7254. Transmitted to the Office of the Secretary 9/23/10. Posted on Master Calendar 9/23/10. (N)
Addendum
Meeting notices printed in this section did not reach the Office of the Secretary in time to meet the Tuesday noon deadline for the previously printed Public Calendar. Under the CPSC Meetings Policy, however, staff persons, including Commissioners, can meet the seven-day notice requirement by placing notice of the meeting on the Master Calendar at least seven days before the meeting. The Master Calendar can be found on CPSC's web site at www.cpsc.gov/calendarmast.html.
In addition, the policy allows the Office of General Counsel to waive the seven-day notice requirements of meetings of the staff personnel, and individual Commissioners can waive the requirements for themselves and their personal staff.
No such meetings listed this week.
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'CPSC 2.0' Launches Product Safety Agency into Social Media -- Learn more at http://www.cpsc.gov/cpscpub/prerel/prhtml09/09346.html
* Visit our new blog, OnSafety at www.cpsc.gov/onsafety
* See our videos on YouTube at http://www.youtube.com/uscpsc
* Follow us on Twitter at http://twitter.com/OnSafety
* See our photos on Flickr at http://www.flickr.com/photos/uscpsc
The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of serious injury or death from thousands of types of consumer products under the agency's jurisdiction. The CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard. The CPSC's work to ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters, and household chemicals - contributed significantly to the decline in the rate of deaths and injuries associated with consumer products over the past 30 years.
To report a dangerous product or a product-related injury, call CPSC's Hotline at (800) 638-2772 or CPSC's teletypewriter at (800) 638-8270. To join a CPSC e-mail subscription list, please go to https://www.cpsc.gov/cpsclist.aspx. Consumers can obtain recall and general safety information by logging on to CPSC's Web site at www.cpsc.gov.
2. "S T U F F" and Paw Wall Hooks Recalled By Midwest-CBK Due to Violation of Lead Paint Standard http://www.cpsc.gov/cpscpub/prerel/prhtml10/10357.html
3. Deaths Prompt CPSC, FDA Warning on Infant Sleep Positioners http://www.cpsc.gov/cpscpub/prerel/prhtml10/10358.html
4. CPSC Public Calendar
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1. NEWS from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs
Washington, DC 20207
FOR IMMEDIATE RELEASE
September 29, 2010
Release #10-356
Firm's Recall Hotline: (866) 229-5570
Sears Recall Hotline: (888) 281-5314
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7058
Black & Decker Recalls Cordless Electric Lawnmowers Due to Laceration Hazard
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.
Name of Product: Black & Decker and Craftsman brand cordless electric lawnmowers
Units: About 160,000 (these lawnmowers were previously recalled in September 2002 for a fire hazard, and that recall was expanded in August 2006)
Manufacturer: Black & Decker (U.S.) Inc., of Towson, Md.
Hazard: The lawnmower's motor and blade can unexpectedly turn on after the mower's safety key is removed, posing a laceration hazard to consumers. Removing the safety key is designed to keep this from occurring.
Incidents/Injuries: Black & Decker has received 34 reports of the motor operating after removal of the safety key, including two incidents that resulted in finger lacerations, one requiring stitches.
Description: The recalled cordless electric mowers were sold under both the Black & Decker and Craftsman brand names. The recalled Black & Decker mowers have model number CMM1000 or CMM1000R. All date codes and types are included. The date code and type information are both located on a silver and black label affixed to the rear door of the mower. The Black & Decker mowers have either an orange or green deck with a black motor cover. The Craftsman-brand mowers have model number 900.370520 and include all date codes and types. The model number is located on the silver and black label affixed to the rear door of the mower. The Craftsman-brand mowers have a dark green deck with a black motor cover.
Sold at: Home center, hardware and discount stores and authorized Black & Decker dealers nationwide from September 1995 through December 2006 for about $450. Craftsman-brand mowers were sold at Sears and Orchard Supply Hardware stores nationwide from January 1998 through December 2000 for about $450.
Manufactured in: United States, Canada and Mexico
Remedy: Consumers should stop using the recalled lawnmowers immediately and call Black & Decker or Sears for a free inspection and repair, or a credit towards a new cordless lawnmower. Consumers who had their mowers repaired as a result of the previous recalls should also have their mowers inspected and repaired as part of this recall.
Consumer Contact: For additional information, consumers with Black & Decker mowers should contact Black & Decker toll-free at (866) 229-5570 between 8 a.m. and 5 p.m. ET Monday through Friday or visit the firm's website at www.blackanddecker.com. Consumers with Craftsman-brand mowers should call Sears toll-free at (888) 281-5314 between 7 a.m. and 9 p.m. CT Monday through Saturday or visit the firm's website at www.sears.com
To see this recall on CPSC's web site, including pictures of the recalled products, please go to:
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10356.html
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2. NEWS from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs
Washington, DC 20207
FOR IMMEDIATE RELEASE
September 29, 2010
Release #10-357 Firm's Recall Hotline: (800) 422-5583
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
"S T U F F" and Paw Wall Hooks Recalled By Midwest-CBK Due to Violation of Lead Paint Standard
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.
Name of Product: "S T U F F" and Paw Wall Hooks
Units: 4,450
Importer: Midwest-CBK, Inc., of Union City, Tenn.
Hazard: Paint on the metal hooks and on the blue paw hook contains excessive levels of lead, violating the federal lead paint standard.
Incidents/Injuries: None reported.
Description: The wall hook sets were sold in three models: model numbers 74641 and 74642, constructed of five separate wooden letters spelling out the word "S T U F F" and model number 65262 consisting of four separate, different colored wooden paws. Model number 74641 has a Purple S, a Red T, an Orange U, a Green F and a Pink F. Model number 74642 has an Olive S, a Blue T, a Yellow U, a White-striped F, and a Blue F. Attached to each letter is a painted metal coat hook with a painted wooden ball at the end. Each letter is approximately 4 inches long, 3/4 inches wide and 9 ¾ inches tall. Model number 65262 has four separate paw-shaped wooden pieces of different colors -- red, blue, green and pink. Attached to each paw is a wooden peg with a wooden ball at the end. The "S T U F F" wall hook sets have a label on the back of the letter "S" that includes the models 74641 or 74642. The Paw wall hook sets have the model number 65262 on the outside of the box.
Sold at: Gift stores, drug stores, furniture stores, décor outlets and variety stores nationwide from December 2008 through August 2010 for between $10 and $30.
Manufactured in: China
Remedy: The wall hook set should be returned to Midwest-CBK for a full refund. Contact Midwest-CBK at the number provided below to receive a prepaid shipping label and merchandise credit.
Consumer Contact: For additional information, contact Midwest-CBK toll-free at (800) 422-5583 between 7:30 a.m. and 5 p.m. CT, Monday through Friday.
To see this recall on CPSC's web site, including pictures of the recalled products, please go to:
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10357.html
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3. NEWS from CPSC and FDA
U.S. Consumer Product Safety Commission www.cpsc.gov
U.S. Food and Drug Administration www.fda.gov
FOR IMMEDIATE RELEASE
September 29, 2010
Release #10-358
CPSC Hotline: (800) 638-2772
FDA Hotline: 888-INFO-FDA
CPSC Media Contact: (301) 504-7908
FDA's Media Contact: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Deaths prompt CPSC, FDA warning on infant sleep positioners
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA) today warned consumers to stop using infant sleep positioners. Over the past 13 years, CPSC and the FDA have received 12 reports of infants between the ages of 1 month and 4 four months who died when they suffocated in sleep positioners or became trapped and suffocated between a sleep positioner and the side of a crib or bassinet.
Most of the infants suffocated after rolling from a side to stomach position. In addition to the reported deaths, CPSC has received dozens of reports of infants who were placed on their backs or sides in sleep positioners, only to be found later in potentially hazardous positions within or next to the sleep positioners.
"The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern to CPSC," said CPSC Chairman Inez Tenenbaum. "We urge parents and caregivers to take our warning seriously and stop using these sleep positioners, so that children can have a safer sleep."
The two main types of infant sleep positioners are flat mats with side bolsters or inclined (wedge) mats with side bolsters.
Both types of sleep positioners typically claim to help keep infants on their backs and reduce the risk of Sudden Infant Death Syndrome (SIDS). The FDA has never cleared an infant sleep positioner to prevent or reduce the risk of SIDS. In addition, CPSC and the FDA are unaware of any scientific studies demonstrating that infant positioners prevent SIDS or are proven to prevent suffocation or other life-threatening harm.
"To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS," said Dr. Joshua Sharfstein, FDA Principal Deputy Commissioner and a pediatrician. "We want to make sure parents, health care professionals, and childcare providers understand the potential risk of suffocation and stop using infant sleep positioners."
Sleep positioners also typically claim to do one or all of the following: aid in food digestion to ease colic or the symptoms of gastroesophageal reflux disease (GERD); and prevent flat head syndrome (plagiocephaly). In light of the new safety data, FDA believes any benefit from using these devices to ease GERD or prevent plagiocephaly is outweighed by the risk of suffocation.
CPSC and the FDA are warning parents and child care providers to:
STOP using sleep positioners. Using a positioner to hold an infant on his or her back or side for sleep is dangerous and unnecessary.
NEVER put pillows, infant sleep positioners, comforters, or quilts under a baby or in a crib.
ALWAYS place an infant on his or her back at night and during nap time. To reduce the risk of SIDS, the American Academy of Pediatrics recommends placing infants to sleep on their backs and not their sides.
The American Academy of Pediatrics does not support the use of any sleep positioner to prevent SIDS.
Manufacturers of infant sleep positioners with medical claims that have not been reviewed by the FDA should stop marketing those products until they submit, and the FDA clears, appropriate premarket review submissions, including necessary safety and effectiveness data.
FDA has informed manufacturers of cleared devices of the agency's serious concern and has requested that they submit clinical data showing the benefits of their products outweigh the risk of suffocation or other serious harm.
Prompt reporting of adverse events can help the FDA and CPSC identify and better understand the risks associated with infant sleep positioners. If you have had a problem with an infant sleep positioner, the agencies encourage you to file a report through FDA's MedWatch program, at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm
CPSC is interested in receiving incident or injury reports related to these products. Please visit https://www.cpsc.gov/cgibin/incident.aspx to file a report.
For more information:
CPSC: Consumer Blog http://www.cpsc.gov/onsafety/2010/09/sleep-positioners-a-suffocation-risk/
FDA: Infant Sleep Positioners Pose Suffocation Risk (Consumer article) http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm227575.htm
FDA: Infant Positioner Initial Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm227301.htm
FDA: Letter to Manufacturers Concerning Medical Claims About Infant Sleep Positioners http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm227302.htm
FDA: Letter to Manufacturers of 510(k)-cleared Infant Positioners http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm227303.htm
NIH: Back to Sleep Campaign http://www.nichd.nih.gov/publications/pubs/safe_sleep_gen.cfm
NIH: Preventing Sudden Infant Death Syndrome and Suffocation www.nichd.nih.gov/health/topics/Sudden_Infant_Death_Syndrome.cfm
AAP: Policy Statement on SIDS http://aappolicy.aappublications.org/cgi/content/full/pediatrics;116/5/1245
About CPSC
The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of injury or death associated with the use of the thousands of types of consumer products under the agency's jurisdiction. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $800 billion annually. The CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard. CPSC's work to ensure the safety of consumer products-such as toys, cribs, power tools, cigarette lighters, and household chemicals-contributed to a significant decline in the rate of deaths and injuries associated with consumer products over the past 30 years.
To report a dangerous product or a product-related injury, call CPSC's Hotline at (800) 638-2772, teletypewriter at 800-638-8270, or visit www.cpsc.gov/talk.html. Consumers can obtain this press release and recall information at www.cpsc.gov.
About FDA
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and quality of human and veterinary drugs, biological products, medical devices, the nation's food supply, cosmetics, and products that emit radiation. The agency works to advance public health through initiatives that drive innovation in drug, medical device, and food science. The FDA is committed to providing accurate, science-based information to the public on the products it regulates. For more information, visit www.fda.gov
Visit FDA on Facebook http://www.facebook.com/FDA
To see this release on CPSC's web site, including pictures of the products involved and the hazard, please go to: http://www.cpsc.gov/cpscpub/prerel/prhtml10/10358.html
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4. CPSC Public Calendar
Vol. XXXVII No. 51
September 29, 2010
U.S. Consumer Product Safety Commission
Bethesda, Maryland 20814
Commission Agendas
Listed below are agendas of Commission Meetings scheduled for the week of October 4, 2010. For a recorded message concerning the latest agenda information call (301) 504-7948.
No such meetings scheduled at this time.
Meetings Between Commission Staff and Outside Parties
All meetings listed below are open to the public unless otherwise stated. For information on a specific meeting or to attend a meeting, please call the contact person listed for that meeting.
Abbreviations: we use asterisks (*) to identify meetings for the current week which have not appeared before in the printed Public Calendar. If the meeting involves discussion of a "substantial interest matter," defined by CPSC's Meetings Policy, we show the date when we posted notice of the meeting on the Master Calendar. The Master Calendar can be found on CPSC's web site at www.cpsc.gov/calendarmast.html. We indicate whether a meeting is of substantial interest by the symbol (S); we use the symbol (N) to indicate non-substantial interest meetings. The Commission offices are located in the Bethesda Towers Building, 4330 East West Highway, Bethesda, Maryland.
Under the Meetings Policy, a staff person holding or attending a substantial interest meeting must file a log of the meeting with the Office of the Secretary within 20 days.
Week of October 4 thru October 10, 2010
Tuesday, October 5
*Commissioner Robert Adler and Counselors Jana Fong- Swamidoss and Jason Levine meeting with Arlene Blum to discuss the end of life for consumer products treated with halogenated flame retardants; 3:30 p.m., Bethesda Towers, room 723. The meeting was requested by Ms. Blum. For additional information contact Ophelia McCardell, (301) 504- 7731. Transmitted to the Office of the Secretary 9/24/10. Posted on Master Calendar 9/24/10. (S)
Wednesday, October 6
Richard O'Brien, Director of International Programs and Intergovernmental Affairs, will speak on the status of implementation of the Consumer Product Safety Improvement Act at the Product Safety and Liability Conference, focusing on its significance for imported products. The presentation will take place at 1:30 p.m., Radisson, Reagan Airport, Arlington, VA. For more information contact Randal Goodden, (262) 594-5198, info@randallgoodden.com. Transmitted to the Office of the Secretary 9/20/10. Posted on Master Calendar 9/21/10. (N)
Thursday, October 7
Mark Kumagai, Directorate for Engineering Sciences, and other CPSC technical staff meeting with Paul Vitrano, Executive Vice President & General Counsel of the Recreational Off-Highway Vehicle Association (ROHVA and ROHVA members) to discuss an update on ROHVA standards development and safety initiatives; 1:00 - 3:00 p.m., Bethesda Towers, room 410 A/B/C. The meeting was requested by Mr. Paul Vitrano. For additional information contact Mark Kumagai, (301) 504-7532. Transmitted to the Office of the Secretary 8/31/10. Posted on Master Calendar 8/31/10. (S)
Future
Tuesday, October 12
Demar Granados, Office of Compliance and Field Operations, and other CPSC staff meeting with Mr. John Rogers and Dr. John Conkling of the American Fireworks Standards Laboratory (AFSL) Standards Committee to discuss the development of an objective test to determine compliance with 16 C.F.R. § 1500.17(a)(3) and (a)(8); 11:00 a.m., Bethesda Towers, room 834. The meeting was requested by AFSL. For additional information contact Demar Granados, (301) 504-7596. Transmitted to the Office of the Secretary 9/23/10. Posted on Master Calendar 9/23/10. (N)
Thursday, October 14
Kristina Hatlelid, Directorate for Health Sciences, and other staff meeting with Jon Bultemeyer, David Turner, and Wolfgang Schaefer of Marabu GmbH & Co. KG to discuss organic inks; 10:00 a.m., Bethesda Towers, room 715. The meeting was requested by Jon Bultemeyer. For additional information contact Kristina Hatlelid, (301) 504-7254. Transmitted to the Office of the Secretary 9/23/10. Posted on Master Calendar 9/23/10. (N)
Addendum
Meeting notices printed in this section did not reach the Office of the Secretary in time to meet the Tuesday noon deadline for the previously printed Public Calendar. Under the CPSC Meetings Policy, however, staff persons, including Commissioners, can meet the seven-day notice requirement by placing notice of the meeting on the Master Calendar at least seven days before the meeting. The Master Calendar can be found on CPSC's web site at www.cpsc.gov/calendarmast.html.
In addition, the policy allows the Office of General Counsel to waive the seven-day notice requirements of meetings of the staff personnel, and individual Commissioners can waive the requirements for themselves and their personal staff.
No such meetings listed this week.
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'CPSC 2.0' Launches Product Safety Agency into Social Media -- Learn more at http://www.cpsc.gov/cpscpub/prerel/prhtml09/09346.html
* Visit our new blog, OnSafety at www.cpsc.gov/onsafety
* See our videos on YouTube at http://www.youtube.com/uscpsc
* Follow us on Twitter at http://twitter.com/OnSafety
* See our photos on Flickr at http://www.flickr.com/photos/uscpsc
The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of serious injury or death from thousands of types of consumer products under the agency's jurisdiction. The CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard. The CPSC's work to ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters, and household chemicals - contributed significantly to the decline in the rate of deaths and injuries associated with consumer products over the past 30 years.
To report a dangerous product or a product-related injury, call CPSC's Hotline at (800) 638-2772 or CPSC's teletypewriter at (800) 638-8270. To join a CPSC e-mail subscription list, please go to https://www.cpsc.gov/cpsclist.aspx. Consumers can obtain recall and general safety information by logging on to CPSC's Web site at www.cpsc.gov.
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THE TIP JAR LIST HAS BEEN UPDATED FOR AUG & SEPT.
To see how you faired, go to: http://misfitscafe.com/tip-jars.txt
==> If your name was not on the list above and you would
like to get ONE of those $100 Tip Jars (absolutely free),
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Many THANKS to all of our MisfitsCafe Sponsors. Beginning
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(or annual) pledges will be entered into a second level of
income earnings. This is designed to help develop a much
larger and consistent monthly income stream (over time).
PLEASE NOTE: this only applies to those who have set up AND
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If your name was not on the Sponsors list above AND followed
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