Recall Z-0834-2007
Kensey Nash Corp · initiated March 28, 2007
Product
FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box.
Codes / lots: Catalog number 60042-02. Lot numbers 49320 exp 4/30/07, 51710 exp 7/31/07, 52340 exp 8/31/07, 52884 exp 9/30/07, 53210 exp 10/31/07, and 53614 exp 10/31/07
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-0834-2007
- Initiated
- March 28, 2007
- Posted by FDA
- May 31, 2007
- Terminated
- August 30, 2007
- Product code
- FRO – Dressing, Wound, Drug
- Quantity
- 109 units
- Distribution
- Worldwide, including USA and Germany.
- Recalling firm
- Kensey Nash Corp, Exton, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0833-2007 | TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm…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 |