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: Legal Blog

Medtronic Recalls Selected Heparin-Coated Products

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Medtronic, Inc., in what is termed a precautionary measure, has voluntary recalled selected products featuring its Carmeda BioActive surface, a coating applied to some devices used in heart bypass surgery and dialysis, because the coating includes contaminated heparin, a blood thinner that has been linked to 81 deaths. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This action was taken subsequent to the U.S. Food and Drug Administration’s April 8, 2008 recommendation to device manufacturers that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action.

Full post as published by Legal Blog on June 12, 2008 (boomark / email).

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