FDA Device recall Z-2772-2026
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01
- FDA Device
- Class II
- ongoing
- Published 2026-07-29
On 2026-07-29 the FDA classified a Class II recall of Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01 by Avid Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2772-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-19 |
| Published | 2026-07-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Avid Medical |
| Distribution | US |
Product
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Reason
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.
Identifiers
| code_info | Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2772-2026%22
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