FDAClass IIJuly 29, 2026

Halyard Standard Line Insertion Pack recall

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

Why was Halyard Standard Line Insertion Pack recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).

Product
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Recalling firm
AVID Medical, Inc.
Quantity
112 kits
Distribution
U.S. Nationwide distribution in the state of California.
Recall date
July 29, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls