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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Carmedacoated

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 Class 2 Device Recall Medtronic Carmedacoatedsee related information
Date Initiated by FirmMay 09, 2008
Date PostedJuly 24, 2008
Recall Status1 Terminated 3 on May 08, 2012
Recall NumberZ-1919-2008
Recall Event ID 48100
510(K)NumberK031700 
Product Classification device for Cardiopulmonary Bypass - Product Code DTN
ProductMedtronic AFFINITY NT Hollow Fiber Oxygenator with Carmeda BioActive Surface, CB511, with Plasma Resistant Fiber. Single Use gas exchange device for Cardiopulmonary Bypass. Catalog Number: 71166
Code Information Catalog / Lot: 71166 / 9821992, 71166 / 9826735. 
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact
763-391-9000
Manufacturer 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).
FDA Determined
Cause 2		Nonconforming Material/Component
ActionMedtronic 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.
Quantity in Commerce84 US, 14 OUS
DistributionWorldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DTN
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