Z-0928-2025 Class II Ongoing

Recalled by Sklar Instruments — West Chester, PA

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: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)

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

96-2478, UDI/DI 50649111492615, Lot codes: SK-121