FDA Medical Device Recalls (openFDA)
Kensey Nash Corp: FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box.
- Recall number
- Z-0834-2007
- Recalling firm
- Kensey Nash Corp
- Product
- FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box.
- Status
- Terminated
- Initiated
- 2007-03-28
- Posted
- 2007-05-31
- Terminated
- 2007-08-30
- 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
- 109 units
- Distribution
- Worldwide, including USA and Germany.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K061772"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 1000307073
- Firm city
- Exton
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28