FDA-Device2025-01-22Class II
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
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
125 units
Manufactured in
1333 Lenape Rd, West Chester, PA, United States
Products
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0926-2025Don't want to check this manually?
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