FDA Medical Device Recalls (openFDA)
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.: CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
- Recall number
- Z-0680-2018
- Recalling firm
- Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
- Product
- CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
- Status
- Terminated
- Initiated
- 2017-07-24
- Posted
- not on file
- Terminated
- 2019-11-07
- Reason
- Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
- Root cause
- Under Investigation by firm
- Action
- Vygon sent recall letters dated July 24, 2017, to customers via email and fax with read receipts and delivery confirmations. The recall letter informed customers of the reason for recall, product description, code and lot number, and instructions to customers, with a Recall Acknowledgement and Inventory Return Form provided/accompanying the recall letter.
- Quantity
- 300 units
- Distribution
- U.S.
- Lot, serial or model codes
- Lot Number: 1706044D
- 510(k) numbers
- ["K954302"]
- PMA numbers
- not on file
- Product code
- LJS
- Firm FEI
- 1000120555
- Firm city
- Dover
- Firm state
- NH
- 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