Wednesday, April 28, 2010

Ocean Management Systems Recalls Scuba Diving Buoyancy Compensators.

Scuba Diving Buoyancy Compensators Recalled by Ocean Management Systems Due to Drowning Hazard (Wed, 28 Apr 2010 15:00:00 GMT) The buoyancy compensator seal ring could crack, posing a drowning hazard to divers.
Name of Product: Buoyancy Compensators used for Scuba Diving
Units: About 20,000
Manufacturer: Ocean Management Systems Inc., of Middletown, N.Y.
Hazard: The buoyancy compensator seal ring could crack, posing a drowning hazard to divers.
Incidents/Injuries: None reported.
Description: This recall involves buoyancy compensators with the following model numbers. Buoyancy compensators provide buoyancy control for scuba divers by allowing them to inflate or deflate the devices. The compensators were sold in black or red. “OMS” is printed on the front inside of the compensators. Item and serial numbers are printed on the warning label located in the non-inflation area of the buoyancy compensator. A list of serial numbers included in this recall is available from the firm.
Item NumberDescription
BC-TCPS- BTACOPS® BC ; Black
BC-TCPS-RTACOPS® BC ; Red
BC116-32B16 BNon retraction single tank BC 32 lb. lift / Black
BC116-32RNon retraction single tank BC 32 lb. lift / Red
BC-LGS45Larry Green Signature Series 45 lb. lift BC
BC-LGS70Larry Green Signature Series 70 lb. lift BC
BC118 - KDual Bladder BC [inflated] 94 lb. lift Black or Red
BC115 - KBDual Bladder BC, 60 lb. lift in Black
BC115 - KRDual Bladder BC, 60 lb. lift in Red
BC118 - KDual Bladder BC [deflated] 94 lb. lift Black or Red
BC117 - K45Single Bladder BC 45 lb. lift / Black
BC117CR - K45Chemically Resistant 45 lb. lift / Black
BC117 - K60Single Bladder BC, 60 lb. lift / Black
BC117 - KBSingle Bladder BC, 94 lb. lift / Black
BC117 - KRSingle Bladder BC, 94 lb. lift / Red
BC116-45BNon-retraction Single Bladder BC 45 lb. lift/ Black
BC116-60BNon-retraction Single Bladder BC 60 lb. lift/ Black
BC116-60RNon-retraction Single Bladder BC 60 lb. lift/ Red
BC116-60CChemically Resistant 60 lb. lift / Black
Sold at: Dive stores nationwide from May 2006 through August 2008 for about $400.
Manufactured in: United States
Remedy: Consumers should immediately stop using the diving equipment and contact Ocean Management Systems to receive a free repair.
Consumer Contact: For additional information, contact Ocean Management Systems toll-free at (877) 791-0315 between 9 a.m. and 4:30 p.m. ET Monday through Friday, visit the firm’s website at www.omsdive.com, or email the firm at recall@omsdive.com
Picture of location of BCA 500 Seal Ring

Picture of Recalled OMS-TCPS-R Buoyancy Compensator
OMS-TCPS-R
Picture of Recalled BC-LGS45 / BC-LGS70 Buoyancy Compensator
BC-LGS45
BC-LGS70
Picture of Recalled BC116-32R Buoyancy Compensator
BC116-32R
Picture of Recalled BC118-K / BC115-KR Buoyancy Compensator
BC118-K
BC115-KR
Picture of Recalled BC117-K45<br>BC117CR-K45 Buoyancy Compensator
BC117-K45
BC117CR-K45

Gogo Sports Recalls Children's Hooded Sweatshirts with Drawstrings

Gogo Sports Recalls Children's Hooded Sweatshirts with Drawstrings Due to Strangulation Hazard (Wed, 28 Apr 2010 15:00:00 GMT) The sweatshirts have a drawstring through the hood that can pose a strangulation hazard to children.
Name of Product: Children’s hooded sweatshirts with drawstrings
Units: About 2,400
Manufacturer: Gogo Sports Inc., of San Francisco, Calif.
Hazard: The sweatshirts have a drawstring through the hood that can pose a strangulation hazard to children. In February 1996, CPSC issued guidelines (pdf) to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper garments, such as jackets and sweatshirts.
Incidents/Injuries: None reported.
Description: This recall involves three styles of children hooded sweatshirts with drawstrings. The zippered sweatshirts were sold in sizes XS through 3XL. The HAY style sweatshirts were sold in black, navy, light grey, charcoal grey and pink. The HKK style sweatshirts were sold in black, navy, light blue, light grey, pink and red. The JMK sweatshirts are reversible microfiber with polar fleece lining and a removable hood with elastic or retractable drawstrings. Style JMK was sold in black only. The sweatshirts have sewn-in neck tag that reads “Gogo Sports” and city names printed across the front of the garment.
Sold at: Clothing retail stores in California, Colorado, Hawaii and New Mexico from January 2008 through December 2009 for between $14 and $27.
Manufactured in: China
Remedy: Consumers should immediately remove the drawstring from the sweatshirts to eliminate the hazard.
Consumer Contact: For additional information, contact Gogo Sports toll-free at (877) 785-1915 between 9 a.m. and 5 p.m. PT Monday through Friday, visit the firm’s Web site at www.gogofleece.com
Picture of recalled sweatshirt

Picture of recalled sweatshirt

Picture of recalled sweatshirt

ICON Health & Fitness Recalls Inversion Benches

ICON Health & Fitness Recalls Inversion Benches Due to Fall Hazard (Wed, 28 Apr 2010 18:30:00 GMT) The ankle clamp can release unexpectedly or the strap used to limit rotation can break, posing a fall hazard to consumers.
Name of Product: Nordic Track Revitalize, Gold’s Gym, and Weider Club Inversion Benches
Units: About 33,000
Distributor: ICON Health & Fitness Inc., of Logan, Utah
Hazard: The ankle clamp can release unexpectedly or the strap used to limit rotation can break, posing a fall hazard to consumers.
Incidents/Injuries: ICON Health & Fitness has received 75 reports of incidents involving the strap breaking or the ankle clamp releasing, including 23 injuries, some of which were to the head and neck.
Description: This recall involves the Nordic Track Revitalize Inversion Bench 2.0 model 831.14895.0, Gold’s Gym Inversion System models GGBE0867.0 and GGCCBE0867.0 and Weider Club Inversion System model WEBE0878.0. The model number is located under the backrest of the bench. The inversion systems consist of a frame with a backrest, headrest and leg clamp assembly.
Sold at: Sporting good stores, Walmart, Sears and other retailers nationwide from April 2008 through February 2009 for between $200 and $300.
Manufactured in: China
Remedy: Consumers should immediately stop using the recalled inversion benches and contact Icon Health & Fitness for a free repair kit.
Consumer Contact: For additional information, contact ICON Health & Fitness toll-free at (866) 506-9095 between 8 a.m. and 4 p.m. MT Monday through Friday, or visit the company’s website at www.iconfitness.com
Model 831.14895.0
Model 831.14895.0

Model WEBE0878.0
Model WEBE0878.0

GGBE0867.0 & GGCCBE0867.0
GGBE0867.0 & GGCCBE0867.0

Monday, April 26, 2010

Covidien Recalls Shiley™ Tracheostomy Tubes

Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes


Company Contact:
Sherri Hughes-Smith
Manager, Media and Public Relation
Respiratory and Monitoring Solutions
303-581-6849
sherri.hughes-smith@covidien.com
Bruce Farmer
Vice President
Public Relations
508-452-4372
bruce.farmer@covidien.com
Coleman Lannum, CFA Vice President
Investor Relations
508-452-4343
cole.lannum@covidien.com
Brian Nameth
Director
Investor Relations
508-452-4363
brian.nameth@covidien.com

FOR IMMEDIATE RELEASE - April 23, 2010 – BOULDER, CO - Covidien (NYSE: COV) has initiated a voluntary recall of certain lots of its cuffed ShileyTM tracheostomy tubes and Custom/Specialty tracheostomy tubes due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly. With respect to the affected units, if a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal. This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation. In some instances, this could result in serious injury, including death.
The voluntary recall only affects lot numbers from a specific period of time. Only Shiley tracheostomy tubes from lot numbers listed below are affected by this action. Customers should review product in inventory and current use to identify product from the affected lot codes. Detailed steps are provided in the Customer Notification letter for return and disposition of affected product.

Product labels are available at FDA and Firms press release.

Customers were notified of this issue by a Customer Notification letter April 13, 2010, which is posted at http://respiratorysolutions.covidien.com/AirwayManagement/tabid/234/Default.aspx1. Then click on the Product Notices tab. 
The company believes it has taken appropriate steps to address this issue. Adequate supplies of unaffected replacement product are available. 
To return the affected product for credit, contact Technical Services group at 1-800-635-5267, option 3, then option 1, and reference the Return Goods Authorization (RGA) Number.  
Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or by phone.  

FORD RECALLS YEAR 2010 FUSION, EXPLORER, EXPLORER SPORT TRAC, AND MERCURY MILAN AND MOUNTAINEER

Vehicle Make / Model:     Model Year(s):
     FORD / EXPLORER     2010
     FORD / EXPLORER SPORT TRAC     2010
     FORD / FUSION     2010
     MERCURY / MILAN     2010
     MERCURY / MOUNTAINEER     2010
Manufacturer: FORD MOTOR COMPANY Mfr's Report Date: APR 16, 2010
NHTSA CAMPAIGN ID Number: 10V161000 NHTSA Action Number: N/A
Component: SEATS:FRONT ASSEMBLY:RECLINER
Potential Number of Units Affected: 33256
Summary:
 FORD IS RECALLING CERTAIN MODEL YEAR 2010 FUSION, EXPLORER, EXPLORER SPORT TRAC, AND MERCURY MILAN AND MOUNTAINEER VEHICLES MANUFACTURED BETWEEN DECEMBER 15, 2009 THROUGH FEBRUARY 3, 2010 EQUIPPED WITH FRONT SEAT MANUAL RECLINERS. THESE VEHICLES FAIL TO COMPLY WITH THE REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 202, ¿HEAD RESTRAINT.¿ THE RECLINER GEAR PLATE TEETH MAY BE OUT OF DIMENSION SPECIFICATION WHICH COULD RESULT IN LIMITED PAWL TO GEAR PLATE TOOTH ENGAGEMENT.
Consequence:
 IN THE EVENT OF A CRASH, THE SEATBACK AND HEAD RESTRAINT MAY MOVE REARWARD, INCREASING THE RISK OF INJURY.
Remedy:
 DEALERS WILL REPLACE THE MANUAL RECLINERS FOR BOTH POWER AND MANUAL SEATS FREE OF CHARGE. THE SAFETY RECALL IS EXPECTED TO BEGIN ON OR BEFORE APRIL 30, 2010. OWNERS MAY CONTACT FORD AT 1-866-436-7332.
Notes:
 OWNERS MAY ALSO CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION'S VEHICLE SAFETY HOTLINE AT 1-888-327-4236 (TTY 1-800-424-9153), OR GO TO HTTP://WWW.SAFERCAR.GOV .

Thursday, April 22, 2010

Beltex Corporation, a Fort Worth, Texas, Recalls 135,500 pounds of beef trim products Due To E. coli O157:H7 Contamination

Recall Release CLASS I RECALL
FSIS-RC-025-2010 HEALTH RISK: HIGH

Congressional and Public Affairs
(202) 720-9113
Adrian Gianforti

WASHINGTON, April 21, 2010 - Beltex Corporation, a Fort Worth, Texas, establishment, is recalling approximately 135,500 pounds of beef trim products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

The following products are subject to recall:
  • Various pound boxes of "FRONTIER MEATS BEEF BONELESS NAVEL"
  • Various pound boxes of "FRONTIER MEATS BEEF TRIMMING 50/50"
  • Various pound boxes of "FRONTIER MEATS BEEF TRACE TRIM"
  • Various pound boxes of "FRONTIER MEATS BEEF COMBO BNLS"
  • Various pound boxes of "FRONTIER MEATS BEEF KIDNEY FAT"
  • Various pound boxes of "FRONTIER MEATS BEEF COMBO TRIM 75/25"
  • Various pound boxes of "FRONTIER MEATS BEEF COMBO TRIM 85/15"
  • Various pound boxes of "FRONTIER MEATS BEEF 115A BNLS CHUCK 2PCS"
  • Various pound boxes of "FRONTIER MEATS BEEF TRIMMING 85/15 VAC PACK"
  • Various pound boxes of "FRONTIER MEATS BEEF B-90 TRIMMINGS 91-CTRN"
  • Various pound boxes of "FRONTIER MEATS BEEF COMBO BNLS NAVEL SOAKED AND SALTED"
  • Various pound boxes of "FRONTIER MEATS BEEF TRIM XF SOAKED AND SALTED"
  • Various pound boxes of "FRONTIER MEATS BEEF TRIM REGULAR SOAKED AND SALTED"
  • Various pound boxes of "FRONTIER MEATS BEEF COMBO TRIM 85/15"
  • Various pound boxes of "FRONTIER MEATS BEEF COMBO BNLS 80/20"
  • Various pound boxes of "FRONTIER MEATS BEEF COMBO BONELESS NAVEL"
Each box bears the establishment number "EST. 07041B" inside the USDA mark of inspection on a label. The products were produced on Oct. 28, 2009, Nov. 20, 2009, Feb. 19, 2010, or April 2, 2010, and were distributed to wholesalers and other federal establishments in the States of Georgia, Louisiana, Ohio, Oklahoma, Texas, Washington and Wisconsin.

The problem was discovered by FSIS during a routine Food Safety Assessment performed at the establishment. The establishment's methods for analyzing samples for E. coli O157:H7 in beef products raised concerns about the safety of the product.

FSIS has received no reports of illnesses associated with consumption of these recalled products. Individuals concerned about an illness should contact a physician.

E. coli O157:H7 is a potentially deadly bacterium that can cause bloody diarrhea, dehydration, and in the most severe cases, kidney failure. The very young, seniors and persons with weak immune systems are the most susceptible to foodborne illness.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers (including restaurants) of the recall and that steps are taken to make certain that the product is no longer available to consumers.

FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume ground beef or ground beef patties that have been cooked to a temperature of 160° F. The only way to be sure ground beef is cooked to a high enough temperature to kill harmful bacteria is to use a food thermometer to measure the internal temperature.

For media and consumer questions regarding the recall should be directed to the company's main line, (817) 624-1136.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.

PORSCHE CARS NORTH AMERICA RECALLS PORSCHE PANAMERA

Vehicle Make / Model:     Model Year(s):
     PORSCHE / PANAMERA     2010
Manufacturer: PORSCHE CARS NORTH AMERICA, INC. Mfr's Report Date: MAR 31, 2010
NHTSA CAMPAIGN ID Number: 10V141000 NHTSA Action Number: N/A
Component: SEAT BELTS:FRONT:ANCHORAGE
Potential Number of Units Affected: 3176
Summary:
 PORSCHE HAS NOTIFIED NHTSA OF A DEFECT IN CERTAIN MODEL YEAR 2010 PANAMERA S, 4S AND TURBO 4-DOOR SEDAN. IF THE FRONT SEATS ARE ADJUSTED TOWARDS AN EXTREME POSITION, RESULTING IN UNFAVORABLE TOLERANCE OF THE MATING COMPONENTS, IT IS POSSIBLE THAT THE FUNCTION OF THE LOCKING MECHANISM OF THE SEAT BELT MOUNT CAN NO LONGER BE GUARANTEED. THE SEAT BELT MOUNT COULD DETACH FROM THE ANCHORING SYSTEM WHEN THE SEAT BELT IS FASTENED OR OPENED.
Consequence:
 IN THE EVENT OF A CRASH, THE SEAT BELT MAY NOT PROVIDE ADEQUATE PROTECTION FOR THE SEAT OCCUPANT, WHICH MAY INCREASE THE RISK OF INJURY OR DEATH.
Remedy:
 DEALERS WILL HAVE AN ADDITIONAL LOCKING ELEMENT INSTALLED ON THE SEAT BELT ANCHORING SYSTEM FOR BOTH FRONT SEATS. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE MANUFACTURER HAS NOT YET PROVIDED AN OWNER NOTIFICATION SCHEDULE. OWNERS MAY CONTACT PORSCHE AT 1-800-545-8039.
Notes:
 PORSCHE RECALL NO. AA01. OWNERS MAY ALSO CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION'S VEHICLE SAFETY HOTLINE AT 1-888-327-4236 (TTY 1-800-424-9153), OR GO TO HTTP://WWW.SAFERCAR.GOV .

BMW RECALLS BMW X5 M SAV VEHICLES

Vehicle Make / Model:     Model Year(s):
     BMW / X5 M SAV     2010
Manufacturer: BMW OF NORTH AMERICA, LLC Mfr's Report Date: APR 08, 2010
NHTSA CAMPAIGN ID Number: 10V152000 NHTSA Action Number: N/A
Component: EXTERIOR LIGHTING
Potential Number of Units Affected:
Summary:
 BMW IS RECALLING CERTAIN MODEL YEAR 2010 X5 M SAV VEHICLES FOR FAILING TO COMPLY WITH THE REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 108, "LAMPS, REFLECTIVE DEVICES, AND ASSOCIATED EQUIPMENT," THESE VEHICLE'S WERE EQUIPPED WITH SIDE MARKER LAMPS, BUT NOT THE POWER SUPPLY CABLES LEADING TO THE LAMPS. AS A RESULT, THE SIDE MARKER LAMPS DO NOT ILLUMINATE.
Consequence:
 THESE VEHICLES DO NOT COMPLY WITH REQUIREMENTS OF FMVSS NO. 108.
Remedy:
 BMW HAS NOT YET PROVIDED A REMEDY OR AN OWNER NOTIFICATION SCHEDULE FOR THIS CAMPAIGN. OWNERS MAY CONTACT BMW AT 800-525-7417.
Notes:
 OWNERS MAY ALSO CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION'S VEHICLE SAFETY HOTLINE AT 1-888-327-4236 (TTY 1-800-424-9153), OR GO TO HTTP://WWW.SAFERCAR.GOV .

TOYOTA IS RECALLS LEXUS GX460 PASSENGER VEHICLES

Vehicle Make / Model:     Model Year(s):
     LEXUS / GX460     2010
Manufacturer: TOYOTA MOTOR NORTH AMERICA, INC. Mfr's Report Date: APR 19, 2010
NHTSA CAMPAIGN ID Number: 10V159000 NHTSA Action Number: N/A
Component: ELECTRONIC STABILITY CONTROL
Potential Number of Units Affected: 9400
Summary:
 TOYOTA IS RECALLING CERTAIN MODEL YEAR 2010 LEXUS GX460 PASSENGER VEHICLES MANUFACTURED FROM NOVEMBER 16, 2009 THROUGH APRIL 8, 2010. IF THE VEHICLE IS DRIVEN THROUGH A SHARP TURN AT HIGH SPEED, THE VEHICLE MAY SKID IN A SIDEWAYS DIRECTION.
Consequence:
 UNDER CERTAIN CONDITIONS THE VEHICLE COULD ROLL OVER AND A CRASH COULD OCCUR.
Remedy:
 TOYOTA WILL NOTIFY OWNERS AND DEALERS WILL REPAIR THE VEHICLES BY REPROGRAMMING THE VEHICLE STABILITY CONTROL FREE OF CHARGE. THE SAFETY RECALL IS EXPECTED TO BEGIN DURING MAY 2010. OWNERS MAY CONTACT TOYOTA AT 1-800-331-4331.
Notes:
 OWNERS MAY ALSO CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION'S VEHICLE SAFETY HOTLINE AT 1-888-327-4236 (TTY 1-800-424-9153), OR GO TO HTTP://WWW.SAFERCAR.GOV .

GA

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