REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
This recall is currently active, issued January 20, 2024. It was issued by Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. Ve Tic. A.S. Akcaburgaz Mahallesi Muhsin Yazicioglu Caddesi No:45/5 Esenyurt Turkey.
- Recall Initiated
- June 9, 2023
- Posted
- January 20, 2024
- Recall Number
- Z-0777-2024
- Quantity
- 4,923,471
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility of Ultrasound gel can not be guaranteed.
Distribution
US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong
Lot / Code Info
Lot Nos. SJ10091019 SJ22111019 SJ01041120 SJ25081020 SJ25061020 SJ20111020 SJ11021021 SJ24061021 SJ03061021 SJ14071021 SJ20091021 SJ09091021 SJ06022023 SJ10091019
Root Cause
Nonconforming Material/Component
Action Taken
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 secil.pala@turkuazsaglik.com.tr .