← FDA ENFORCEMENT
Z-3108-2026Class I
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
2026-09-23
Distribution
US Nationwide distribution in the state of NE.
Firm state
VA
Product quantity
288 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
Product description
Halyard IV START KIT NON-STERILE REF: KRIV26-02
Code / lot info
Lot Number: 1658437 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 →