Z-0947-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2025
- Initiation Date
- December 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0 units
Product Description
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 Pattern
Domestic: Nationwide Distribution
Code Information
1) 96-4134M, UDI/DI 50649111492547, Lot codes: SK-114; 2) 96-4137M, UDI/DI 50649111492530, Lot codes: SK-116.