FDA recall Z-0949-2025

Sklar Instruments · Class II · device

Product

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

Domestic: Nationwide Distribution

Key facts

Status
Ongoing
Initiation date
2024-12-03
Report date
2025-01-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0949-2025