FDA recall Z-3194-2026

Product

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.

Reason for recall

Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2026-07-22

Report date

2026-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toano, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3194-2026