Z-0934-2025 Class II Ongoing
FDA device recall Z-0934-2025 was initiated by Sklar Instruments on December 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: 25 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2025
- Initiation Date
- December 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 units
Product Description
ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
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
96-2245M, UDI/DI 50649111448612, Lot codes: 0724962245M