Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.
FDA device recall Z-0617-2007 · posted 2007-03-14 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.
- Action taken
- Consignees will be notified via letter dated 12/12/06, which provides instructions for identifying defective manual drives and to contact the firm if their unit is defective.
- Root cause
- Other
- Status
- Terminated
- Product code
- KFM
- Quantity affected
- 2696
- Distribution
- Woldwide, including USA, Canada, and Mexico
- Date initiated
- 2006-12-12
- Date posted
- 2007-03-14
- Date terminated
- 2008-06-19
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTRIFUGAL PUMP SYSTEM LX/DX VERSION (K882758) | 3M Health Care, Sarns | 1988-10-13 |