Consumer Lawyers

Archive for June, 2013|Monthly archive page

Lipari Foods Recalls Sunflower Seeds

In FDA REcalls on June 22, 2013 at 8:32 pm

Lipari Foods of Warren, MI is recalling Raw Sunflower Seeds, Roasted Sunflower Seeds and Snack Mixes, because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Raw Sunflower Seeds, Roasted Sunflower Seeds, and Snack Mixes were distributed from April 5th 2013 to June 11th 2013 to manufacturers and retailers in the following states: Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.

In total there are 52 items affected by this recall. Please see attached documentation for complete list of products including UPC and lot codes. Detailed information will be mailed out to each store affected by the recall.–17024034/

Endologix’s Catheter Introducer Device Recall

In FDA REcalls on June 22, 2013 at 8:31 pm

The FDA designated an Endologix (NSDQ:ELGX) warning over a catheter introducer as a Class I recall, meaning the device could seriously injure or kill patients.

The Irvine, Calif.-based company received reports that the dilator component of its AFX introducer system can break off during procedures.

Endologix sent a letter to customers in Florida, Indiana, Michigan, New Hampshire, New Jersey and New York, the only states where the defective introducer system was distributed.

Medtronic recalls surgical breathing tube

In FDA REcalls on June 22, 2013 at 8:30 pm

Medtronic Inc. has recalled a breathing tube used during surgery that could collapse and imperil a patient’s breathing if handled incorrectly, the Food and Drug Administration said Friday.

It was the first public mention of the problem but the Fridley-based medical device marker said the recall was begun in March and completed in April, and that no deaths or injuries were reported. The product, called a NIM Trivantage EMG Endotracheal Tube, was manufactured at Medtronic’s Jacksonville, Fla., operations.

The FDA announced the recall on its website Friday because it had classified the recall’s degree of seriousness. It was classified a Class One recall, which the FDA said on its website means “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

The endotracheal tube is used during surgery for ventilation and for monitoring the muscles of the voice box. A cuff around the tube, used to close the gap around the tube that delivers air and anesthesia, can become deflated if the device is handled incorrectly. This may require a doctor to reinflate the cuff or replace the tube to make sure the patient can continue to breathe.

Beta Labs, LTD Announces Recall of Oxyphen, Phentalene, Phen FX, and Red Vipers

In FDA REcalls on June 22, 2013 at 8:29 pm
Beta Labs, LTD (“Beta”), dietary supplement retailer, is recalling Oxyphen XR Lot #s 200910 and 200911, Phentalene Lot # 58800512, Phen FX Lot # 1205129, and Red Vipers Lot # 1205128 (hereinafter referred to as the “Products”). The recall was initiated on June 15, 2013, after a review of recent FDA communications related to 1,3 dimethylamylamine (“DMAA”). The Products contain DMAA.
The UPC codes for each of the products are: Oxyphen XR, 70541 59974; Phentalene, 70541 59982; Phen FX, 29882 55980; Red Vipers, 29882 55981. The Products are all in capsule form.
DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. The Food and Drug Administration (FDA) has warned that DMAA is potentially dangerous to health.
See Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems. A number of adverse effects associated with DMAA containing dietary supplements have been reported to the FDA. The FDA has also warned that DMAA is not a dietary ingredient and thus, is not Dietary Supplement Health and Education Act (DSHEA) compliant.
This recall affects Oxyphen XR Lot #s 200910 and 200911, Phentalene Lot # 58800512, Phen FX Lot # 1205129, and Red Vipers Lot # 1205128. The products are in capsule form.