Medical device recalls Moderate risk

Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. recalls REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

Recall date
June 9, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0777-2024
FDA classification
Class II
Brand / firm
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
Sold / distributed
US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong

Why it was recalled

Sterility of Ultrasound gel can not be guaranteed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

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