Recall Z-1425-06 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Cobe Cardiovascular, Inc
Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung Packs), Catalog Numbers: 028901008, 032794001, 067129002, 067149006, 067174002, 067188002, 067212004, 067221009, 067236004, 067260001, 067296002, 067351006, 067354002, 067388004, 067434005, 067442001, 067447010, 067452001, 067458005, 067481003, 06748002, 067523001, 067529002, 067536002, 067539005, 067570003, 067577001, 06
| Date | Aug 24, 2006 (initiated Jun 26, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Consignees were notified by letter on 06/26/2006. |
| Quantity | 3438 units (Domestic) |
| Distribution | Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan |
| FDA record | Open on fda.gov |