Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Procedure Kits, P/N 3ZZ164275X, 3ZZ
FDA device recall Z-2606-2010 · posted 2010-09-28 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Corporation
- Reason for recall
- Medical device component may malfunction and require user intervention during surgical bypass procedures.
- Action taken
- The recalling firm notified end users, perfusion groups, and distributors by phone, fax, email and mail on 03/15/10 to advise of the required recall actions with instructions for labeling and returning the involved product from the customer level. The firm expanded their recall to include additional lots on 05/17/10. If you have any questions, please contact Customer Service at 800-521-2818.
- Root cause
- Other
- Status
- Terminated
- Product code
- KFM
- Quantity affected
- 28257 pumps
- Distribution
- The product was sold to medical device distributors and to direct accounts nationwide and to a subsidiary in Japan.
- Date initiated
- 2010-03-15
- Date posted
- 2010-09-28
- Date terminated
- 2011-11-04
- Location
- Elkton, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X (K020998) | Terumo Cardiovascular Systems Corp. | 2002-04-04 |