FDA Enforcement
Class II
Ongoing
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
Recall: Z-0928-2025
·
Reported January 22, 2025
Enforcement
- Recall Number
- Z-0928-2025
- Event ID
- 95946
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Sklar Instruments
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 22, 2025
- Initiation Date
- December 3, 2024
- Classification Date
- January 16, 2025
- Address
- 1333 Lenape Rd, West Chester, PA, 19382-6816, United States
Description
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
Reason
Reports of various packaging issues that may result in a breach of the sterile barrier.
Code Info
96-2478, UDI/DI 50649111492615, Lot codes: SK-121
Distribution
Domestic: Nationwide Distribution
Quantity
0 units