← FDA ENFORCEMENT
Z-3109-2026Class II

AVID Medical, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
AVID Medical, Inc.
Product type
Device
Status
Ongoing
Report date
2026-09-16
Distribution
US Nationwide distribution in the state of NE.
Firm state
VA
Product quantity
98 Kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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.

Product description

Halyard IV Start Kit Non-Sterile REF: KRIV26-02

Code / lot info

Lot Number:1658438 7/31/2026 UDI: 10809160460481

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →