Blood Center Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. Q921CL, Manufactured for : Blood Center of Wisconsin, Milwaukee, WI. Port VAD Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. 3540CL, Manufactured for : McCormick Medical Distribution, Edmonds, WA 98020. The kits are used by blood centers to draw blood.
FDA Recall Z-0894-2011 · Posted 2011-01-11
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Recalling FirmContinental Medical Labs,Inc
Recall StatusTerminated
Product CodeOFM
Date Initiated2010-12-06
Date Terminated2012-07-05
Product Quantity30 cases, 30 kits per case
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.
Firm Action
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
Distribution Pattern
Nationwide Distribution including WA and WI
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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