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Open, Classified

Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.

FDA Recall Z-2772-2026 · Posted 2026-07-22

Recalling FirmAVID Medical, Inc.
Recall StatusOpen, Classified
Product CodeOES
Date Initiated2026-05-19
Product Quantity112 kits

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.

Firm Action

AVID Medical notified consignees on about 05/19/2026 via email. Consignees were instructed to identify, segregate, and quarantine all impacted kits, and add the provided warning labels to affected AVID kits to ensure all users are aware of discarding the impacted component prior to use. Distributors were instructed to ensure all end-users are properly notified if affected kits have been further distributed. Customers/End-users were instructed that if they have received product from a distributor, to contact the distributor or your sales representative with any questions. Recipients were requested to complete and return the provided Recall Response Form.

Root Cause

Process change control

Distribution Pattern

U.S. Nationwide distribution in the state of California.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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