Z-0948-2025 Class II Ongoing
FDA device recall Z-0948-2025 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
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0 units
Product Description
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
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
96-4146A, UDI/DI 50649111492707, Lot Codes: SK-136
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0948-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026