FDA Medical Device Recalls (openFDA)
Vygon Corporation: Premicath 28G PICC Catheter
- Recall number
- Z-0090-06
- Recalling firm
- Vygon Corporation
- Product
- Premicath 28G PICC Catheter
- Status
- Terminated
- Initiated
- 2005-06-27
- Posted
- 2005-10-28
- Terminated
- 2005-10-31
- Reason
- Guidewire protuding from tip of the catheter
- Root cause
- Other
- Action
- The recalling firm issued a recall letter via fax to the distributors on 6/27/05. The letter informed the distributors of the problem and to notify any hospital accounts of the problem and the need to trim the catheter prior to implantation.
- Quantity
- 243 units
- Distribution
- The product was shipped to distributors in CA, CO, FL, IL, MD, NJ, NY, OH, PA, TX and WA.
- Lot, serial or model codes
- Lot numbers 014434 and 012615
- 510(k) numbers
- ["K041468"]
- PMA numbers
- not on file
- Product code
- LJS
- Firm FEI
- 2245270
- Firm city
- Norristown
- 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