FDAFDA recall Z-2772-2026 · Jul 29, 2026
AVID Medical, Inc.: Halyard STANDARD LINE INSERTION PACK recall
Recall found
Product
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).
- Quantity
- 112 kits
- Distribution
- U.S. Nationwide distribution in the state of California.
- Recalling firm
- AVID Medical, Inc., Toano, VA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-19
Source: openFDA enforcement record Z-2772-2026 · search recall number Z-2772-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.