FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box.
FDA device recall Z-0834-2007 · posted 2007-05-31 · Terminated
Recall details
- Recalling firm
- Kensey Nash Corp
- Reason for recall
- Insufficient wire sealing
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 109 units
- Distribution
- Worldwide, including USA and Germany.
- Date initiated
- 2007-03-28
- Date posted
- 2007-05-31
- Date terminated
- 2007-08-30
- Location
- Exton, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIACTIV FX EMBOLIC PROTECTION SYSTEM (K061772) | Kensey Nash Corp. | 2006-07-11 |