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U.S. Department of Health and Human Services

Class 2 Device Recall Halyard STANDARD LINE INSERTION PACK

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 Class 2 Device Recall Halyard STANDARD LINE INSERTION PACKsee related information
Date Initiated by FirmMay 19, 2026
Date PostedJuly 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2772-2026
Recall Event ID 99250
Product Classification Cardiac catheterization kit - Product Code OES
ProductHalyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Code Information Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).
FEI Number 1047429
Recalling Firm/
Manufacturer		 AVID Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
For Additional Information ContactMarlene Jones
757-566-3510
Manufacturer 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.
FDA Determined
Cause 2		Process change control
ActionAVID 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.
Quantity in Commerce112 kits
DistributionU.S. Nationwide distribution in the state of California.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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