Notice names this product. AVID Medical’s Halyard STANDARD LINE INSERTION PACK is named in FDA Class II recall Z-2772-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).. Units affected: 112 kits. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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.
Company / brand: AVID Medical
Affected product: Halyard STANDARD LINE INSERTION PACK
Official ID Z-2772-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.