—#70943

Product

Medtronic Affinity Pediatric arterial Filter, Arterial Line Filter for Cardiopulmonary Bypass. Catalog Number: CB4014

FDA product code: DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K071253
Affected lot / code info: Catalog / Lot: CB4014 / 9827678

Why it was recalled

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).

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern: Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.

Timeline

Recall initiated: 2008-05-09
Posted by FDA: 2008-07-24
Terminated: 2012-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70943. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.