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

FDA device recall Z-2772-2026 · posted 2026-07-22 · Open, Classified

Recall details

Recalling firm

AVID Medical, Inc.

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.

Action taken

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

Status

Open, Classified

Product code

OES

Quantity affected

112 kits

Distribution

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

Date initiated

2026-05-19

Date posted

2026-07-22

Location

Toano, VA