FDA Device recall Z-1688-2022
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
- FDA Device
- Class II
- ongoing
- Published 2022-09-14
On 2022-09-14 the FDA classified a Class II recall of VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS by Stradis Healthcare, citing potential for incomplete seals.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1688-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-10 |
| Published | 2022-09-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stradis Healthcare |
| Distribution | PA |
Product
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Reason
Potential for incomplete seals.
Identifiers
| code_info | Part Number AMS-8465CS, UDI/DI: 00849884005622, Lot Number: 220614962, Expiration Date: 04/30/2023 |
|---|
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-1688-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.