Medical device recalls Moderate risk

Sklar Instruments recalls Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERI…

Recall date
December 3, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0950-2025
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

Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery

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