Recall Z-2447-2008 ยท FMF Syringe, Piston
Smith & Nephew Inc
Caption Disposable Platelet Concentrator Kit, Ref 71178202, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN 38116
| Date | Sep 20, 2008 (initiated Aug 5, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 v |
| Quantity | 568 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041976 | SMITH & NEPHEW GRAFT DELIVERY SYSTEM Smith & Nephew, Inc., Aug 23, 2004 |