FDA recall Z-1741-2025

AVID Medical, Inc. · Class II · device

Product

Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit

Reason for recall

An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.

Distribution

US Nationwide distribution in the states of IL & LA.

Key facts

Status: Ongoing
Initiation date: 2025-03-31
Report date: 2025-05-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Toano, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1741-2025