Recall Z-0894-2011 ยท OFM Phlebotomy Blood Collection Kit
Continental Medical Labs,Inc
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.
| Date | Jan 11, 2011 (initiated Dec 6, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Material/Component Contamination |
| 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 rec |
| Quantity | 30 cases, 30 kits per case |
| Distribution | Nationwide Distribution including WA and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.