FDAFDA · Food and drugs·Recall number Z-0777-2024
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
Published January 31, 2024 · Recall initiated: June 9, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterility of Ultrasound gel can not be guaranteed.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
- Distributor
- US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong
- Lot
- Lot Nos. SJ10091019 SJ22111019 SJ01041120 SJ25081020 SJ25061020 SJ20111020 SJ11021021 SJ24061021 SJ03061021 SJ14071021 SJ20091021 SJ09091021 SJ06022023 SJ10091019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Turkey
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