Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile, Catalog Number 436422974, COBE Cardiovascular, Inc.. (shipped International only for use in Heart/Lung packs)
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-1428-06
- Quantity
- 30 units (Australia)
- 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
Lot number 0610800082.
Root Cause
Other
Action Taken
Consignees were notified by letter on 06/26/2006.
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