FDA Medical Device Recalls (openFDA)
Vygon Corporation: Churchill Medical Systems AMS-7080CP (Dressing Change Kit). The device intended use is a dressing change kit.
- Recall number
- Z-2388-2011
- Recalling firm
- Vygon Corporation
- Product
- Churchill Medical Systems AMS-7080CP (Dressing Change Kit). The device intended use is a dressing change kit.
- Status
- Terminated
- Initiated
- 2011-04-19
- Posted
- 2011-06-11
- Terminated
- 2012-06-18
- Reason
- Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.
- Root cause
- Nonconforming Material/Component
- Action
- A recall letter printed on Vygon letterhead dated April 20, 2011 and specific to each customer was sent via overnight courier mail. The letter described the affected product, issue and actions to take. Customers were instructed to check their inventory for the recalled products, cease use and distribution, and quarantine all affected product. Each customer received a custom copy of the letter with the specific product codes and lots that were shipped to them described in the Recall Acknowledgement and Inventory Return Form. Distributors were provided with instructions on how to handle product that was further distributed by them. The firm issued an updated Recall Notice dated May 31, 2011 to two consignees effected by the expanded recall. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.
- Quantity
- 7,900 units
- Distribution
- United States (FL, MA, MD, and VA).
- Lot, serial or model codes
- Lot Numbers: 10J29, 10J55, 11A18, 11A47 and 11B06.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LKB
- Firm FEI
- 2245270
- Firm city
- Montgomeryville
- 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