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U.S. Department of Health and Human Services

Class 2 Device Recall COBE Autotransfusion set.

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 Class 2 Device Recall COBE Autotransfusion set.see related information
Date Initiated by FirmAugust 04, 2006
Date PostedSeptember 09, 2006
Recall Status1 Terminated 3 on December 28, 2011
Recall NumberZ-1491-06
Recall Event ID 36168
510(K)NumberK020647 
Product Classification autotransfusion set - Product Code CAC
ProductCobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17. Cobe Cardiovascular Inc.
Code Information COBE Product Code-ASCBFE22, Lot numbers: 0610100225, 0613000077, 0615700007, 0618600109, 0621300094-- COBE Product Code-ASCBE22, Lot Numbers: 0608000247, 0610800007, 0612300036, 0613000076, 0613600146, 0615700006, 0617200003, 0617800128, 0619200116, 0619900053, 0621300093--COBE Product Code- AS9E55, Lot Numbers: 0617200004, 0619900054, 0621300095-COBE Product Code- AS9E22, Lot Numbers: 0611600047, 0612300034, 0613000075, 0614300116, 0617200002, 0617800127, 0618600107, 0621300092--COBE Product Code- AS9E12, Lot Numbers: 0612300035, 0615000022, 0616400011, 0618600108, 0619900052-COBE Product Code- AS4E55, Lot Numbers: 0616400012, 0618600110- COBE Product Code-AS4E22, Lot Numbers: 0609400006, 0610100223, 0615700005, 0619900051-COBE Product Code- AS4E17, Lot Numbers: 0613600145, 0616400013, 0617200005, 0619900055.
FEI Number 1718850
Recalling Firm/
Manufacturer		 Cobe Cardiovascular, Inc
14401 W 65th Way
Arvada CO 80004-3524
For Additional Information ContactJack Ellison
303-467-6306
Manufacturer Reason
for Recall		Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
FDA Determined
Cause 2		Other
ActionConsignees were notified by telephone and e-mail on 08/04/2006.
Quantity in Commerce8,964 wash sets, 1,518 Stat pacs-Recalls Z-1488-1491-06
DistributionNationwide, including VA facilities in CA and OH
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 = CAC
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