FDA Medical Device Recalls (openFDA)
Vygon U.S.A.: Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
- Recall number
- Z-1689-2021
- Recalling firm
- Vygon U.S.A.
- Product
- Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
- Status
- Open, Classified
- Initiated
- 2021-04-15
- Posted
- not on file
- Terminated
- not on file
- Reason
- Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
- Root cause
- Under Investigation by firm
- Action
- Vygon USA issued Urgent Medical Device Recall letter via email on 4/15/21. Letter states reason for recall, health risk and action to take: The recall will be conducted at no cost to you; all inventory will be credited or replaced at no cost to you. To complete the return of the recalled product and replacement with new inventory, we request your cooperation in the following steps: 1. Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product. 2. Count and document your affected inventory on the Recall Acknowledgement and Inventory Return Form in Attachment 1. Please complete and return the document even if you currently have no product on hand. 3. Fax or email the form to Vygon including customer contact information. 4. Vygon customer service will contact you to issue a Return Merchandise Authorization number. 5. Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up. If you have any questions, please contact your sales representative or Vygons Customer Service Department at 1-800-473-5414 (M-F, 8am-6pm), or by e-mail at customerservice@vygonus.com.
- Quantity
- 8,320 units
- Distribution
- US Nationwide distribution in the state of PA.
- Lot, serial or model codes
- Lot Number: 203373129 Exp. Date: June 30, 2022
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OXQ
- Firm FEI
- 2245270
- Firm city
- Lansdale
- 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