Z-1689-2021Class II

Vygon Dressing Change w/ Maxiswab -

Name: Z-1689-2021 Vygon Dressing Change w/ Maxiswab -
Creator: Vygon U.S.A.
Published: 2021-04-15
License: https://open.fda.gov/license/

Vygon U.S.A. / initiated 2021-04-15 / Open, Classified / root cause: packaging

FDA source

Vygon U.S.A. began a recall of Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS on 2021-04-15. FDA classified it as Class II and gives the reason as "Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1689-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-15
Posted: 2021-05-28
Recalling firm: Vygon U.S.A.
Product: Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Product code: OXQ Dressing Change Tray
Reason for recall: 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 tag: packaging
FDA 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 [email protected].
Quantity in commerce: 8,320 units
Distribution: US Nationwide distribution in the state of PA.
Product codes and lots: Lot Number: 203373129 Exp. Date: June 30, 2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1689-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1689-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-09	2021-05-28

Product code OXQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)