Recall Z-0833-2007
Kensey Nash Corp · initiated March 28, 2007
Product
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.
Codes / lots: Catalog numbers 60040-02 and 60040-03. Lot numbers 49709 exp 3/31/07, 51844 exp 5/31/07, 52822 exp 7/31/07, 53209 exp 5/31/07, 53252 exp 7/31/07, 54264 exp 7/31/07, 54276 exp 11/30/07, 49912 exp 3/30/07, 50952 exp 5/31/07, 51714 exp 7/31/07, 52488 exp 5/31/07, and 54248 exp 11/30/07.
Reason for recall
Insufficient wire sealing
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0833-2007
- Initiated
- March 28, 2007
- Posted by FDA
- May 31, 2007
- Terminated
- August 30, 2007
- Product code
- FRO – Dressing, Wound, Drug
- Quantity
- 427 kits
- Distribution
- Worldwide, including USA and Germany.
- Recalling firm
- Kensey Nash Corp, Exton, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0834-2007 | FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is…Insufficient wire sealing | 03/28/2007Terminated |
| Z-0835-2007 | ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product…Insufficient wire sealing | 03/28/2007Terminated |