Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The centrifugal pump is designated as
FDA device recall Z-0140-06 · posted 2005-11-16 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- Small cracks in the blood chamber may allow air to enter the rotor of the device
- Action taken
- Terumo notified consignees by telephone on 7/26/05 and followed by letter dated 7/28/05. Accounts are requested to return product.
- Root cause
- Other
- Status
- Terminated
- Product code
- KFM
- Quantity affected
- 893 kits
- Distribution
- AZ, CA, KY, IL, LA, MD, WA , WI
- Date initiated
- 2005-07-26
- Date posted
- 2005-11-16
- Date terminated
- 2006-05-02
- 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 |
|---|---|---|
| CAPIOX SP PUMP HEAD (K962981) | Terumo Medical Corp. | 1997-02-25 |