Covidien recalls mislabelled insulin syringes
According to a Reuters report, during the packaging process some syringes labelled as U-40 insulin were mixed with U-100 insulin, raising the possibility that patients may unknowingly administer 2.5 times the desired dose, resulting in serious health consequences.
The Associated Press reports that around 4,710 boxes were distributed in the recalled lot, affecting about 471,000 syringes. The syringes, distributed by Can-Am Care, were sold at Wal-Mart stores and Sam's Clubs under the ReliOn name.
Bermuda-based Covidien, which initiated the voluntary recall on October 9 according to the US Food and Drug Administration (FDA), has asked that any remaining product is removed from the shelves and placed in quarantine until further analysis can take place.
To date the FDA has received one adverse event report associated with a ReliOn syringe from the affected batch although the agency has yet to issue a formal confirmation statement.
Covidien is advising customers to return any affected products in exchange for a replacement. The firm has also set up a dedicated website to manage the recall, which can be accessed here.
The news is another blow for Covidien’s syringe unit. In March this year the firm was forced to withdraw batches of its range of heparin products as part of a nation-wide recall of the active pharmaceutical ingredient (API) on contamination worries.