Thursday, November 6, 2008

Covidien calls back mislabeled insulin syringes

By Mass High Tech Staff

Medical device maker Covidien Ltd. is recalling 471,000 of its ReliOn insulin syringes nationwide, based on concerns over package mislabeling.

The U.S. Food and Drug Administration announced Wednesday that the Mansfield-based company was recalling one lot of its ReliOn syringes sold at Wal-Mart Corp. stores between Aug. 1 and Oct. 8 of this year. Patients using these could possibly receive an overdose of as much as 2.5 times the intended dosage amount. This could cause hypoglycemia or other adverse reactions, and even death.

These ReliOn products have a syringe barrel and a hypodermic needle attached to the tip of the syringe. The error, according to the FDA announcement, occurred during the packaging, when syringes marked for use with U-40 insulin were mixed with U-100-labeled syringes. The syringes were all packed in 100-unit boxes marked for use with U-100 insulin. Covidien distributed 4,710 of these boxes for sale by Wal-Mart, which retailed them at its stores and Sam’s Clubs, under the ReliOn brand name.

Covidien has received one “adverse report” from the use of one of the syringes. Covidien voluntarily recalled the lot — number 813900 — on Oct. 9, requesting the units be taken from the shelves and quarantined. 

According to the FDA announcement, Wal-Mart is asking all affected customers to return the syringes for replacement. Additionally, Wal-Mart has posted news of the recall in its stores and on its website. It has also issued letters to more than 16,500 customers.

In 2007, Covidien reported $6 billion in medical device revenue, down from $8.8 billion in 2006. Covidien claims it employs 6,100 in its regional offices, up from 5,000 in 2006.