FDA Recall
Open, Classified
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
Recall: Z-0777-2024
·
Initiated June 9, 2023
Recall
- Recall Number
- Z-0777-2024
- Event Number
- 93580
- Firm
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. Akcaburgaz Mahallesi Muhsin Yazicioglu Caddesi No:45/5 Esenyurt Turkey
- FEI Number
- 3009482034
- Product Code
- MUI
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- June 9, 2023
- Posted
- January 20, 2024
Description
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
Reason
Sterility of Ultrasound gel can not be guaranteed.
Action
On June 5, 2023, Turkuaz issued a "Field Safety Notice to affected consignee(s). On December 13, 2023, an updated notification was provided to affected consignee(s) Turkuaz asked consignees to return the recalled items or destroy them. If you have any questions, email the Quality Director at [email protected] .
Distribution
US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong
Quantity
4,923,471