Summary
The FDA issued a Class II for Halyard IV Start Kit Non-Sterile REF: KRIV26-02 by AVID Medical, Inc.. Reason: Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the pap.
Details
Source
Device Recall
External ID
Z-3109-2026
Action Date
2026-09-16
Status
Ongoing
Category
device
Product Description
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Lot/Code Info: Lot Number:1658438 7/31/2026 UDI: 10809160460481
Quantity Affected: 98 Kits
Reason for Recall
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.
Distribution
US Nationwide distribution in the state of NE.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-14
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 180 device recalls issued in the same week, part of 445 device-related FDA actions this month.
AVID Medical, Inc. has 150 FDA actions in our database, including 150 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 150 FDA actions in our database, including 150 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3109-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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