Z-0949-2025 Class II Ongoing

Recalled by Sklar Instruments — West Chester, PA

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
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¿¿ ¿