| | Class 2 Device Recall Cobe Blood oxygenator |  |
| Date Initiated by Firm | June 26, 2006 |
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| Date Posted | August 24, 2006 |
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| Recall Status1 |
Terminated 3 on August 08, 2011 |
| Recall Number | Z-1428-06 |
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| Recall Event ID |
35839 |
| Product Classification |
Blood Oxygenator - Product Code DTZ
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| Product | Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile, Catalog Number 436422974, COBE Cardiovascular, Inc.. (shipped International only for use in Heart/Lung packs) |
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| Code Information |
Lot number 0610800082. |
Recalling Firm/
Manufacturer |
Cobe Cardiovascular, Inc
14401 W 65th Way
Arvada CO 80004-3524
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| For Additional Information Contact |
303-467-6306 |
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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. |
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FDA Determined
Cause 2 | Other |
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| Action | Consignees were notified by letter on 06/26/2006. |
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| Quantity in Commerce | 30 units (Australia) |
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| Distribution | Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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