Z-0943-2025 Class II Ongoing
FDA device recall Z-0943-2025 was initiated by Sklar Instruments on Dec 3, 2024 and is designated Class II. Reason for recall: Reports of various packaging issues that may result in a breach of the sterile barrier. The recall status is ongoing. Affected quantity: 0 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 22, 2025
- Initiation Date
- Dec 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0 units
Product Description
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical biopsy
Reason for Recall
Reports of various packaging issues that may result in a breach of the sterile barrier.
Distribution Pattern
Domestic: Nationwide Distribution
Code Information
1) 96-4113, UDI/DI 50649111492899, Lot codes: SK-133; 2) 96-4144A, UDI/DI 50649111492523, Lot codes: HSC21; 3) 96-4145A, UDI/DI 50649111492608, Lot codes: HSC21.