FDA Medical Device Recalls (openFDA)
Vygon Neuro: 10 cm Scopable Catheter Reservoir
- Recall number
- Z-0367-06
- Recalling firm
- Vygon Neuro
- Product
- 10 cm Scopable Catheter Reservoir
- Status
- Terminated
- Initiated
- 2005-03-24
- Posted
- 2006-01-10
- Terminated
- 2006-01-10
- Reason
- stylet in package is shorter than that claimed on the label
- Root cause
- Other
- Action
- The recalling firm issued a letter to their customers informing them of the problem and the need to return the product.
- Quantity
- 14 units
- Distribution
- The product was shipped to a hospital in CA and a distributor in Germany.
- Lot, serial or model codes
- N0297/SRS10/03-2009
- 510(k) numbers
- ["K853361","K853362"]
- PMA numbers
- not on file
- Product code
- HCA
- 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