FDA Medical Device Recalls (openFDA)
Vygon US LLC: Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle.
- Recall number
- Z-0160-04
- Recalling firm
- Vygon US LLC
- Product
- Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle.
- Status
- Terminated
- Initiated
- 2003-09-09
- Posted
- 2003-11-27
- Terminated
- 2003-11-26
- Reason
- mislabeled as sterile
- Root cause
- Other
- Action
- The recalling firm issued recall letters to their direct accounts via fax on 9/9/03. The letter informed the accounts of the problem and the need to sterilize the product or return it for replacements.
- Quantity
- 3 units
- Distribution
- The products were shipped to one distributor in NY and two hospitals in TX and UT. The products were also shipped to distributors in Holland, Greece, Austria, Norway, Taiwan, and Finland.
- Lot, serial or model codes
- Catalog number SP01, Lot numbers H0359, J0107, and J0493.
- 510(k) numbers
- ["K853370"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 2518608
- 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