FDA recall Z-0936-2025

Product

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general purpose clips

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Distribution

Domestic: Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2024-12-03

Report date

2025-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0936-2025