FDA recall Z-0947-2025

Product

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy

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-0947-2025