FDA Device recall Z-1689-2021
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS
- FDA Device
- Class II
- ongoing
- Published 2021-06-09
On 2021-06-09 the FDA classified a Class II recall of Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS by Vygon U, citing compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1689-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-15 |
| Published | 2021-06-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Vygon U |
| Distribution | US |
Product
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Reason
Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
Identifiers
| code_info | Lot Number: 203373129 Exp. Date: June 30, 2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1689-2021%22
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