FDA recall Z-0777-2024
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. · Class II · device
Product
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
Reason for recall
Sterility of Ultrasound gel can not be guaranteed.
Distribution
US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong
Key facts
- Status
- Ongoing
- Initiation date
- 2023-06-09
- Report date
- 2024-01-31
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Esenyurt, N/A, Turkey
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0777-2024