FDAHealthMay 19, 2026
AVID Medical, Inc. — Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
⚠️ Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 19, 2026
U.S. Nationwide distribution in the state of California.
What's affected?
- Product
- Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
- Brand
- AVID Medical, Inc.
- Lot code
- (Expiration
Additional details
Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 112 kits.
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