medical Class II Updated 2025-01-22

Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO

Recalled 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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1) 96-4134M, UDI/DI 50649111492547, Lot codes: SK-114; 2) 96-4137M, UDI/DI 50649111492530, Lot codes: SK-116.
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