Medline Guidewires Recalled over Serious Coating Problems

The FDA recently designated a Medline Industries guidewires recall as Class I.The Medline guidewire is identified as the ACME Monaco Guidewire .035x150 3MMJ TCFC item number 88241, with affected products distributed between March 2013 and August 2013.The guidewire is used in various surgical convenience kits assembled and marketed by Medline Industries. It is meant to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.The guidewires in question, however, have the potential for the coating to flake off of the wire, according to the FDA. A Class I designation means the agency believes that the faulty guidewires could cause serious adverse health consequences or death.

Mundelein, IL-based Medline sent recall notifications to customers in August 2013, telling them to examine their inventory, and affix a provided sticker on the affected kits warning users that the Acme Monaco Guidewire .035X150 3MMJ TCFC item number 88241 has been recalled and should not be used. Customers were told to return the affected guidewires to Medline, though they could replace the affected guidewires with sterile product and use the rest of the kit.The FDA has listed the product codes and lot numbers for the recalled guidewires:054372-1-1A, 054372-1-1B, 054372-1-2A.As of February 28, this was only the second Class I medical device recall listed on the FDA's site for the month. The other was Teleflex Medical Inc.'s voluntary recall of a faulty tracheal tube.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.