Z-0949-2025 Class II Ongoing
FDA device recall Z-0949-2025 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: 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
- units
Product Description
ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
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
96-3814, UDI/DI 50649111455986, Lot codes: 050824-01¿¿ ¿