Recall Z-0833-2007 ยท FRO Dressing, Wound, Drug
Kensey Nash Corp
TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.
| 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 | 427 kits |
| 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 |