Halyard STANDARD LINE INSERTION PACK Recall for Silicone Seal Defect
AVID Medical is recalling 112 Halyard STANDARD LINE INSERTION PACKs due to silicone seal defects that may cause fluid leakage or occlusion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with risk-of-harm potential from fluid leakage/occlusion, but no reported injuries or illnesses per the rubric for risk-of-harm products without reported injury.
Plain-English summary
AVID Medical, Inc. is recalling 112 Halyard STANDARD LINE INSERTION PACKs (Model/Catalog Number: PVHM234-01) due to defects in the silicone seal. The defects may cause the silicone seal to dome due to improper sealing, potentially leading to fluid occlusion or leakage. The affected kits were distributed in California and have expiration dates of 5/31/2026 and 8/31/2026. No illnesses or injuries have been reported. Consumers should stop using the product and contact AVID Medical for a replacement or refund.
The recalled product
- Product
- Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 112
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 1599022 (5/31/2026).
Distribution
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