Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Summary
The FDA issued a Class II for Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Conv by AVID Medical, Inc.. 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 lea.
Details
Source
Device Recall
External ID
Z-2772-2026
Action Date
2026-07-29
Status
Ongoing
Category
device
Product Description
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Lot/Code Info: Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).
Quantity Affected: 112 kits
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.
Distribution
U.S. Nationwide distribution in the state of California.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-19
Company
Toano, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 373 device-related FDA actions this month.
AVID Medical, Inc. has 127 FDA actions in our database, including 127 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AVID Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AVID Medical, Inc. have FDA actions?
AVID Medical, Inc. has 127 FDA actions in our database, including 127 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2772-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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