PlainRecordsFDA · Medical device recall
VYGON DRESSING CHANGE W/MAXISWAB kit…
- Date
- Sept. 14, 2022
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing
- Filed by
- Stradis Healthcare
- Product
- VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
- Reason
- Potential for incomplete seals.
- Distribution pattern
- Pennsylvania
- Quantity
- 520 units
- Codes and lots
- Part Number AMS-8465CS, UDI/DI: 00849884005622, Lot Number: 220614962, Expiration Date: 04/30/2023
- Recall started
- May 10, 2022
- Device type
- Dressing Change Tray
- Root cause (FDA)
- Other
- What the company told customers
- Stradis notified its sole consignee initially by telephone on 05/10/2022 and followed with a letter disseminated by email on 05/11/2022. The letter explained the problem, risk to health, and requested the quarantine of the affected product pending return. The letter directed the consignee to notify their customers to whom they further distributed the product to return the product to Stradis.
- Recall number
- Z-1688-2022
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement report, recall number Z-1688-2022. The agency record governs; check it and the company before acting.