Recall Ledger

Halyard IV START KIT NON-STERILE REF: KRIV26-02 recall (AVID Medical, Inc.)

Medical deviceClass IOngoing

Summary: AVID Medical, Inc. is recalling Halyard IV START KIT NON-STERILE REF: KRIV26-02. Reason: Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides.

What is being recalled

Halyard IV START KIT NON-STERILE REF: KRIV26-02

Why

Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides

How serious is it

Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.

Where it was sold

US Nationwide distribution in the state of NE. (states named: Nebraska)

How to tell if yours is affected

Lot Number: 1658437 UDI: 10809160460481

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-3108-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass I
StatusOngoing
Recall startedJuly 14, 2026
ReportedSeptember 23, 2026
CompanyAVID Medical, Inc.
Company locationToano, VA, United States
Initiated byVoluntary: Firm initiated
Quantity288 units

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Official FDA record