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U.S. Department of Health and Human Services

Class 2 Device Recall Cardioplegia Delivery Set

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 Class 2 Device Recall Cardioplegia Delivery Setsee related information
Date Initiated by FirmMay 25, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on March 31, 2005
Recall NumberZ-1009-04
Recall Event ID 29261
510(K)NumberK934847 
Product Classification Reservoir, Blood, Cardiopulmonary Bypass - Product Code DTN
ProductCardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt
Code Information Catalog # 027770201, Lot # 0406800015.
Recalling Firm/
Manufacturer		 Cobe Cardiovascular, Inc
14401 W 65th Way
Arvada CO 80004-3524
For Additional Information Contact
303-425-5508
Manufacturer Reason
for Recall		Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia.
FDA Determined
Cause 2		Other
ActionCustomers were notified by telephone on 5/25/2004 and by letter on 6/3/2004.
Quantity in Commerce216 sets
DistributionAL, AZ, FL, KS, MN, MO, NV, TX, WI. Foreign distribution to Canada.
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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