Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda BioActive Surface, Catalog Number: CB511, CB5201R14, and CB5227R4.
FDA Recall Z-1922-2008 · Posted 2008-07-24
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Recalling FirmMedtronic Perfusion Systems
Recall StatusTerminated
Product CodeDTZ
Date Initiated2008-05-09
Date Terminated2012-05-08
Product Quantity147 US, 19 OUS
Reason for Recall
Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS).
Firm Action
Medtronic issued a Press Release on 05/07/2008. An Urgent Medical Device Recall letter was sent to customers on May 07, 2008. The letter identifies affected devices, explains the situation and requests that the impacted product be returned to Medtronic for disposal. The end user will be requested to complete a Recall Certificate acknowledging the receipt of this information.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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