Blood Center Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. Q921CL, Manufactured for : Bl

FDA device recall Z-0894-2011 · posted 2011-01-11 · Terminated

Recall details

Recalling firm

Continental Medical Labs,Inc

Reason for recall

Continental Medical labs, Inc, is recalling various lots of Blood Center Kit and Port VAD Kits because Covidien reported that testing could not pick up an Over-Sulfated Chondroitin Sulfate (OSCS) contaminant in the purified heparin sodium USP.

Action taken

Covidien sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to their distributors. Continental Medical Labs,Inc telephoned on 12/06/2010 and later sent a letter dated December 7, 2010, with an enclosed copy of the recall notice. The letters were addressed to McCormick Medical Distribution, Inc and to Medico Mart, Inc. The letter described the problem and product affected. Advised consignees to inform all their customers to return the product as well as the distribution information as soon as possible so CML could notify Covidien for replacements. For questions regarding this recall call (262) 723-6715, ext. 313.

Root cause

Material/Component Contamination

Status

Terminated

Product code

OFM

Quantity affected

30 cases, 30 kits per case

Distribution

Nationwide Distribution including WA and WI

Date initiated

2010-12-06

Date posted

2011-01-11

Date terminated

2012-07-05

Location

Waterford, WI