FDA-Device2025-01-22Class II
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
Sklar Instruments
Hazard
Reports of various packaging issues that may result in a breach of the sterile barrier.
Sold states
Domestic: Nationwide Distribution
Affected count
0 units
Manufactured in
1333 Lenape Rd, West Chester, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0947-2025Don't want to check this manually?
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