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U.S. Department of Health and Human Services

Class 2 Device Recall Custom heart lung perfusion packs

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 Class 2 Device Recall Custom heart lung perfusion packssee related information
Date Initiated by FirmOctober 06, 2005
Date PostedDecember 02, 2005
Recall Status1 Terminated 3 on August 05, 2011
Recall NumberZ-0265-06
Recall Event ID 33842
Product Classification Filter, Blood, Cardiopulmonary Bypass, Arterial Line - Product Code DTM
ProductCustom heart lung perfusion packs
Code Information 210 unique catalog numbers with 779 unique lot numbers.
Recalling Firm/
Manufacturer		 Cobe Cardiovascular, Inc
14401 W 65th Way
Arvada CO 80004-3524
For Additional Information Contact
303-467-6306
Manufacturer Reason
for Recall		One way valve in the heart lung pack assembly may be missing.
FDA Determined
Cause 2		Other
ActionConsignees notified by letter on 10/06/2005.
Quantity in Commerce21,512 units
DistributionNation wide, including VA facilities in FL, NM, & CO and military facilities in CA, VA, & WA.
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.
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