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Recall Observatory FDA recall evidence

Device product

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

Z-0950-2025

December 03, 2024

Class II

Product summary

Firm
Sklar Instruments
Event
Event 95946
Status
Ongoing
Classification
Class II
Quantity
350 units
Official record key
device-enforcement:Z-0950-2025

Official wording

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

Code information: 1) 96-2540, UDI/DI 50649111054967, Lot codes: FSS8, FSS10; 2) 96-2541, UDI/DI 50649111055087, Lot codes: FSS10; 3) 96-2542, UDI/DI 50649111055391, Lot codes: FSS10; 4) 96-2542M, UDI/DI 50649111440685, Lot codes: MSS10.

Distribution pattern: Domestic: Nationwide Distribution

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of the sterile barrier