Z-2772-2026 Class II Ongoing
FDA device recall Z-2772-2026 was initiated by AVID Medical, Inc. on May 19, 2026 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 112 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- May 19, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 112 kits
Product Description
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Reason for Recall
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.
Distribution Pattern
U.S. Nationwide distribution in the state of California.
Code Information
Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).