Recall Z-0835-2007 ยท FRO Dressing, Wound, Drug
Kensey Nash Corp
ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box.
| Date | May 31, 2007 (initiated Mar 28, 2007) |
| Status | Terminated |
| Reason | Insufficient wire sealing |
| Root cause | Other |
| Action | On 3/26/07, the recalling firm left voice mail message with all sales representatives instructing the sales representatives to contact all TriActiv FX accounts immediately. Recall notices were faxed on 3/28/07 to all accounts which received the product. Recall notices instructed the hospitals to quarantine all FX and to contact their sales representative to arrange for retrieval of the product if they had not already been contacted. |
| Quantity | 11 units |
| Distribution | Worldwide, including USA and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061772 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM Kensey Nash Corp., Jul 11, 2006 |