Recall Z-2772-2026 ยท OES Cardiac Catheterization Kit
AVID Medical, Inc.
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
| Date | Jul 22, 2026 (initiated May 19, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process change control |
| 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 reques |
| Quantity | 112 kits |
| Distribution | U.S. Nationwide distribution in the state of California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.