Urgen Recall Notice: ReliOn Diabetic Insulin Syringes Recalled

Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. These syringes are sold only by Wal-Mart or Sam's Club pharmacies under the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes. FDA urges patients and health care professionals to check syringe packaging carefully for products with this lot number, not to use the product, and return the product to the pharmacy for replacement. The lot number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”.

If you or a loved one have been injured as a result of using one of the recalled ReliOn Insulin Syringes you may be entitled to compensation. If you have questions regarding your legal rights contact our ReliOn Insulin Syringe attorneys today. The ReliOn Insulin lawyers of Ennis & Ennis, P.A. are standing by to answer any questions you may have about the ReliOn Insulin Syringe Recall a ReliOn Insulin Syringe lawsuit or a possible ReliOn Insulin Syringe class action lawsuit. With offices in Washington D.C. and throughout Florida, we are ready to help ReliOn Insulin Syringe victims nationwide. Let our ReliOn Insulin Syringe Attorneys evaluate your case for free today. Fill out our free online case evaluation form or call us toll free at: 1-800-856-6405 for your free, confidential case evaluation.

Class 1 Recall: Tyco Healthcare Group LP (Covidien), ReliOn Insulin Syringes, 1cc, 31-Gauge

Date Recall
Initiated:
 October 9, 2008
Product:

ReliOn Insulin Syringes, 1cc, 31-gauge, 100 units for use with U-100 insulin, Lot Number 813900, Product Code 38396-0403-02

Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are subject to this recall.

This product was manufactured in June 2008 and distributed from July through October 8, 2008.
Use:

An insulin injection is used to control blood sugar in people who have type 1 or type 2 diabetes and who cannot control their diabetes with oral medicines.

Recalling Firm:
 Covidien LP
15 Hampshire St
Mansfield, Massachusetts 02048-1113
Reason for Recall:

Some packages were mislabeled. The syringes labeled for use with U-40 unit insulin were mixed with syringes labeled for use with U-100 insulin. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia (abnormally low level of blood sugar), serious health consequences, and even death.

Public Contact:
 Customers may return the recalled product to their local Wal-Mart store or Sam’s Club pharmacy for replacement product. Consumers and healthcare professionals who suspect they have the recalled product may also contact Covidien at 1-866-780-5436 or www.relion.com/recall for more information.
FDA District:
 New England
FDA Comment:

Tyco Healthcare Group, LP (Covidien) notified Can-Am Care, Corporation (the distributor of these syringes) by letter sent by e-mail and by Federal Express on October 9, 2008. The letter requests that they immediately:

  • inventory, quarantine and return any remaining stock they may have of the product, and
  • notify their customers.

Can-Am Care, whose name appears on the product label, has also posted a notice on their website.

Wal-Mart and Sam’s Clubs conducted consumer mailings on Oct. 14, 2008, posted the recall announcement in their stores, and on Wal-Mart’s website, and are posting placards (posters) in their stores.

Wal-Mart and Sam’s Club are asking their customers to return ReliOn 1cc, 31-gauge syringes labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam’s Club pharmacy for a replacement product.

For additional information, see FDA’s Press Release at http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

If you or a loved one have been injured as a result of using one of the recalled ReliOn Insulin Syringes you may be entitled to compensation. If you have questions regarding your legal rights contact our ReliOn Insulin Syringe attorneys today. The ReliOn Insulin lawyers of Ennis & Ennis, P.A. are standing by to answer any questions you may have about the ReliOn Insulin Syringe Recall a ReliOn Insulin Syringe lawsuit or a possible ReliOn Insulin Syringe class action lawsuit. With offices in Washington D.C. and throughout Florida, we are ready to help ReliOn Insulin Syringe victims nationwide. Let our ReliOn Insulin Syringe Attorneys evaluate your case for free today. Fill out our free online case evaluation form or call us toll free at: 1-800-856-6405 for your free, confidential case evaluation.

For more information regarding the ReliOn Insulin Syringe Recall Visit our ReliOn Insulin Syringe News Archive

Posted by Ennislaw at 11/12/2008 12:57 PM
Categories: ReliOn Insulin Syringe
 

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