FDA recall Z-3109-2026

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2026-07-14

Report date

2026-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toano, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3109-2026