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U.S. Department of Health and Human Services

Class 2 Device Recall COBE Blood oxygenator

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  Class 2 Device Recall COBE Blood oxygenator see related information
Date Initiated by Firm June 26, 2006
Date Posted August 24, 2006
Recall Status1 Terminated 3 on August 08, 2011
Recall Number Z-1422-06
Recall Event ID 35839
510(K)Number K926467  K974812  
Product Classification Blood oxygenator - Product Code DTZ
Product Cobe Optima XP Hollow Fiber Membrane Oxygenator/Reservoir, Sterile, (Standalone Systems) Catalog Numbers 050255500, 050316400, 050412400, 050500000. COBE Cardiovascular, Inc..
Code Information Catalog # 050255500, Lot Numbers 0608000009, 0610800078, 0613600057...Catalog # 050316400, Lot Numbers 0607300017, 0608000011, 0608700110, 0608800063, 0609400137, 0610100174, 0610200062, 0610800080, 0611600081, 0612200144, 0612900020, 0612900039, 0613600059....Catalog # 050412400, Lot Number 0608000010, 0608700109, 0609400136, 0610800079, 0611600080, 0612200143, 0612900038, 0613000001.... Catalog # 050500000, Lot Number 0609400138, 0610100176, 0611600082, 0612200146.
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		 Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the surface area needed for proper heat transfer.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 06/26/2006.
Quantity in Commerce 2204 units (Domestic)
Distribution Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DTZ and Original Applicant = COBE CARDIOVASCULAR, INC.
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