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Open, Classified

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

FDA Recall Z-0777-2024 · Posted 2024-01-20

Recalling FirmTurkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
Recall StatusOpen, Classified
Product CodeMUI
Date Initiated2023-06-09
Product Quantity4,923,471

Reason for Recall

Sterility of Ultrasound gel can not be guaranteed.

Firm 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] .

Root Cause

Nonconforming Material/Component

Distribution Pattern

US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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