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Thursday, July 30, 2009

Abbott Recalls POWERSAIL® Coronary Dilatation Catheters

Abbott Issues Voluntary Recall of POWERSAIL® Coronary Dilatation Catheters

Media:
Jonathon Hamilton
(408) 845-3491

Financial:
Tina Ventura
(847) 935-9390

FOR IMMEDIATE RELEASE - ABBOTT PARK, Ill. - July 28, 2009 - Abbott has conducted a voluntary recall of three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage. While the issue could be detected and avoided during the preparation for use of the product, it may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.

Abbott Vascular's sales representatives contacted all customers affected by this action and instructed them to cease use of any units from the part numbers and lot numbers listed below. All outstanding units are in the company's possession or are in transit. Patients who have already been treated are not affected by this action.

Product Designation Product Number Lot
Number
Expiration Date
POWERSAIL® 3.25x18mm (U.S.)

1005524-18

7101051

09-2009

POWERSAIL® 4.0x8mm (CE)

1005726-08

7112051

10-2009

POWERSAIL® 2.75x18mm (U.S.)

1005522-18

8012151

12-2009

POWERSAIL® 3.25x8mm (U.S.)

1005524-08

8053061

04-2010

Three out of the four complaints of distal shaft damage resulted in no adverse patient effects. One complaint reported that the patient had evidence of a post-procedural myocardial infarction. Subsequently, the patient was reported to be doing well.

The United States Food and Drug Administration (FDA) has been apprised of this action, and it has classified this action as a Class I recall.

The POWERSAIL Coronary Dilatation Catheter is distributed for prescription use only to approved U.S. and international health care organizations. Affected devices can be identified by the part number and lot number combinations shown above.

Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Wednesday, July 29, 2009

Frontera Produce Recalls One Lot of Cilantro Due To Salmonella Contamination

Frontera Produce Recalls One Lot of Cilantro Because of Possible Health Risk

Contact:
Amy Gates
877-381-5701
fpltd.mail@fronteraproduce.com

FOR IMMEDIATE RELEASE - July 28th, 2009 - Frontera Produce, of Edinburg, TX, is voluntarily recalling one lot of cilantro because it has the potential to be contaminated with salmonella. The company is working with the FDA to inform consumers of this recall, and no illnesses have been reported to date.

Salmonella, is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The lot in question, 118122, was distributed to two retail store chains in Texas, Oklahoma, Colorado, Louisiana, and New Mexico. Both chains were provided with case tag identification and have been advised of the recall. Frontera Produce is issuing this voluntary recall as an additional measure to advise consumers to destroy the cilantro described above, purchased between July 20, 2009 and July 27, 2009. The cilantro bunches in question have a white twist tie with pink lettering spelling the word 'Cilantro' and the UPC number 033383801049.

The recall involves only one lot of cilantro and does not involve any other products.

This product originated in Mexico and was procured by Frontera Produce, who subsequently routinely tested for contaminants as part of their internal food safety program.

"Frontera Produce continues to stay committed to the highest levels of food safety, and strives to work within the industry to bring food safety to the forefront. We continually look for ways to enhance our protocol and stay committed to providing outstanding products to our consumers," said Will Steele, President and CEO.

Consumers with questions may contact Frontera Produce at 1(877)-381-5701, Monday-Friday, 9am-5pm central standard time, or email fpltd.mail@fronteraproduce.com.

Wednesday, July 1, 2009

Intermatic Inc Recalls Intermatic Model ST01 and EI600 In-wall Electronic Timers.

Intermatic Recalls In-Wall Timers Due to Shock Hazard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Intermatic Inc., of Spring Grove, Ill., is voluntarily recalling about 240,000 Intermatic Model ST01 and EI600 In-wall Electronic Timers. When consumers trying to replace the timer’s battery place a metal object through the battery tray slot, the object can reach internal metal contacts, posing a shock hazard to consumers.

LTD Commodities LLC Recalls Ionic Salt Lamps

Lamps Recalled by LTD Commodities LLC, ABC Distributing and the Lakeside Collection Due to Fire Hazard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), LTD Commodities LLC; ABC Distributing of Bannockburn, Ill., and Lakeside Collection, all of Bannockburn, Ill., are voluntarily recalling about 25,800 Ionic Salt Lamps. The lamps overheat causing the vinyl coating on the cord to burst and melt, posing a fire hazard to consumers.

Polaris Industries Inc Recalls 2009 Polaris Assault model Snowmobiles.

Polaris Recalls Snowmobiles Due to Loss of Control Hazard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Polaris Industries Inc., of Medina, Minn., is voluntarily recalling about 800 2009 Polaris Assault model Snowmobiles. Bolts on the rear suspension can break causing the rail tip to become dislodged and interfere with the snowmobile’s track. This can cause the track to lock up and the rider to lose control of the snowmobile, posing a risk of injury.

MarineTech Products Inc RecallsTabletop Rope Cutters

bulletTabletop Rope Cutters Recalled by MarineTech Products Due to Fire and Burn Hazards

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), MarineTech Products Inc., of White Bear Lake, Minn., is voluntarily recalling about 450 Tabletop Rope Cutters. The recalled rope cutters can overheat, posing fire and burn hazards.