Cobe Optima XP Hollow Fiber Membrane Oxygenator/Reservoir, Sterile, (Standalone Systems) Catalog Numbers 050255500, 050316400, 050412400, 050500000. COBE Cardiovascular, Inc..
This recall has been terminated (originally issued August 24, 2006).
- Company
- Cobe Cardiovascular, Inc
- Recall Initiated
- June 26, 2006
- Posted
- August 24, 2006
- Terminated
- August 8, 2011
- Recall Number
- Z-1422-06
- Quantity
- 2204 units (Domestic)
- Firm Location
- Arvada, CO
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan
Lot / Code Info
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.
Root Cause
Other
Action Taken
Consignees were notified by letter on 06/26/2006.