Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN 38116.
FDA device recall Z-2446-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- Product contained a syringe whose package seal integrity can be adversely affected when the product is exposed to low atmospheric pressure. This may occur during shipping.
- Action taken
- Prior to the dissemination of the official notices, the firm notified personnel at our field offices of the BD syringe recall and advised that a subsequent recall of our Caption devices would follow. High volume users were contacted via phone on July 30th and the 31st and personnel at all affected field offices were notified via email on July 30, 2008 with an Urgent Medical Device Recall Letter. The firm requedsted that usere immediately cease distribution, examin the stock on hand and the stock of the accounts that have been suppplied and remove any affected ecices from all inventory. A verification notification was included with letter
- Root cause
- Other
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 364 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-08-05
- Date posted
- 2008-09-20
- Date terminated
- 2010-05-28
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMITH & NEPHEW GRAFT DELIVERY SYSTEM (K041976) | Smith & Nephew, Inc. | 2004-08-23 |