Tuesday, November 11, 2008

Alert: Diabetic Insulin Syringes Recalled

  • Product name: ReliOn® Insulin Syringes 31-gauge, 1cc
  • Lot number: 813900
  • Product identification number: 38396-0403-02

Adding to the long list of recent recalls, people with diabetes using ReliOn® insulin syringes should check their boxes. On November 5, 2008, the Food and Drug Administration (FDA) Website publicized notice of the ReliOn® Insulin Syringe Recall. The syringes being recalled from lot number 813900 are labeled as “ReliOn® 1cc, 31-gauge, 100 units for the use of U-100 insulin”. Tyco Healthcare Group LP, (Covidien) the manufacturer, ceased distribution of these possibly defective insulin syringes on October 8, 2008.

On October 9, 2008 ReliOn® issued a voluntary recall of the syringes. These sterile, single-use, syringes with permanently affixed needles are being recalled for the reason some are mislabeled and have a potential for overdose risk. Somehow during their production process, syringes labeled for U-40 insulin use were packaged with syringes labeled for U-100 insulin and then distributed.

The questionable insulin syringes were manufactured by Tyco Healthcare Group LP, distributed by Can-Am Care Corporation, and sold exclusively at Sam’s Clubs and Wal-Mart stores under the ReliOn® Insulin Syringe brand name. Around 4,710 boxes each containing 100 syringes, for a total of about 471,000 syringes, were distributed by Can-Am Care Corporation to Sam’s Clubs and Wal-Mart stores under the ReliOn® name between August 1 to October 8, 2008. However, they could have been sold even after this date. Around 16,500 customers who purchased the syringes in stores and on line from their websites have been notified to return the recalled syringes to their local Sam’s Club or Wal-Mart Pharmacy.

The FDA has advised patients and healthcare providers to carefully check for these recalled syringes. Unfortunately, use of a flawed ReliOn® syringe could deliver a two and a half times larger dose than ordered, resulting in hypoglycemia, or low blood sugar. Initial signs and symptoms of hypoglycemia include:

· Confusion

· Dizziness

· Hunger

· Heart palpitations

· Sweating

· Nausea

· Headache

· Tremors

· Anxiety

If a person is left untreated, it can rapidly progress into:

· Disorientation

· Seizures

· Loss of consciousness

· Coma

· Death

Regrettably, the manufacturer has reported one such incident to the FDA. A month ago, Shirley Payne, of Virginia, was stabilized and recovered after she fell victim to the faulty syringes. Healthcare workers and consumers are urged to report serious adverse side effects, or product quality problems from the use of this product to the FDA’s MedWatch Adverse Event Reporting program by mail, FAX, online, or phone. Either call 1-800-332-1088 or go to www.fda.gov/MedWatch/report.htm. For further information, consumers can call Covidien at 1-866-780-5436 or go to http://www.relion.com/recall/.

Even though consumers are assured a replacement package, several attorneys are evaluating individuals who suffered adverse reactions or serious injury, and are investigating for potential lawsuits. They caution although Sam’s Club and Wal-Mart Pharmacies are exchanging the insulin syringes from the recalled lot, individuals who have suffered injury who intend to pursue the syringe recall lawsuit should preserve their remaining syringes until their case has been reviewed. They caution any needles not returned should be stored and marked in a way to prevent against their usage.

All things considered, who knows how many people this affected and whether we will ever know the truth. In any case, it makes one question what happened to this company’s quality assurance department. When lawsuits are started, hush money keeps us from knowing the extent of the truth. In conclusion, this incident is just another example of our country’s deteriorating structures.








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