|Covidien is recalling certain lots of its Monoject syringes.--Courtesy of Covidien|
Covidien ($COV) is voluntarily recalling lots of its Monoject prefilled syringes, warning that some were never sterilized and could put patients at risk for infection if used.
The recall affects 6 lots of syringes full of either sodium chloride or heparin and sold in the U.S. and Bermuda. Covidien said the syringes may have missed out on the autoclave sterilization process during manufacturing, and most have no visual cues that could help physicians identify which are safe.
The company informed customers on Friday, asking them to cross-check lot numbers and return affected products. The FDA is aware of the recall but hasn't assigned a class designation to it. The agency accepts adverse event reports through its online MedWatch platform.
Syringes fall under Covidien's medical supplies business, a segment that accounts for about 17% of the company's total revenue now that its pharma business has spun out and settled down as Mallinckrodt ($MNK). Last quarter, the unit slipped about 1% to $439 million as declines in SharpSafety and surgical products weighed down gains in the company's nursing care business.
The company expects between 1% and 2% annual growth in medical supplies, setting the high end at about $1.6 billion for the year, and a 4% to 6% increase for the medical devices unit, making for up to $3.9 billion in 2013 revenue.
- read Covidien's statement