Medical device recalls Moderate risk

Sklar Instruments recalls ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-…

Recall date
December 3, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0926-2025
FDA classification
Class II
Brand / firm
Sklar Instruments
Sold / distributed
Domestic: Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)

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