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Recall Observatory FDA recall evidence

Device product

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)

Z-0926-2025

December 03, 2024

Class II

Product summary

Firm
Sklar Instruments
Event
Event 95946
Status
Ongoing
Classification
Class II
Quantity
125 units
Official record key
device-enforcement:Z-0926-2025

Official wording

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

Code information: 1) 96-2483, UDI/DI 50649111449053, Lot codes: FSS5; 2) 96-2484, UDI/DI 50649111492950, Lot codes: SK-115

Distribution pattern: Domestic: Nationwide Distribution

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of the sterile barrier