AVID Medical, Inc. recalls Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience…

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2772-2026
• FDA device classification · OESOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find AVID Medical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.