Haemonetics Basic Low Volume (125ml) Cell Saver 5 Bowl Set List Number: 261
FDA device recall Z-0500-03 · posted 2003-01-30 · Terminated
Recall details
- Recalling firm
- Haemonetics Corporation
- Reason for recall
- Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
- Action taken
- Haemonetics notified accounts of the recall on December 17, 2002 by fax. A hard copy of the same letter was sent to each customer via certified mail, return receipt on December 18 and 19. Users are requested to cease use of product and return product to Haemonetics.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAC
- Quantity affected
- 4138
- Distribution
- Nationwide Canada
- Date initiated
- 2002-12-17
- Date posted
- 2003-01-30
- Date terminated
- 2016-01-28
- Location
- Braintree, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL SAVER 5 SYSTEM (K932890) | Haemonetics Corp. | 1994-01-05 |