FDAHealthJune 11, 2025
AVID Medical, Inc. — GS ENDOSCOPY PACK. Medical convenience kit.
⚠️ CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Is this relevant to me?
- Geography
- CA, IL, MD, OH, PA, TX, WA
- Source agency
- FDA
- Category
- Health
- Published
- June 11, 2025
Domestic: CA, IL, MD, OH, PA, TX, WA.
What's affected?
- Product
- GS ENDOSCOPY PACK. Medical convenience kit.
- Brand
- AVID Medical, Inc.
- Lot code
- No
Additional details
Model No. NAMC421-10, NAMC421-11, NAMC421-12; UDI: 10809160374597, 10809160417539, 10809160435779; Kit Lot No. 1584375, 1588403, 1605341, 1615427, 1615428, 1627706, 1628153, 1628008, 1628009, 1628647, 1632992.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 816 units.
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