FDA recall Z-0446-2025

Product

Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-09-20

Report date

2024-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toano, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0446-2025