PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: January 31, 2024 Initiated: June 9, 2023 #Z-0777-2024

Product Description

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

Reason for Recall

Sterility of Ultrasound gel can not be guaranteed.

Details

Units Affected
4,923,471
Distribution
US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong
Location
Esenyurt, N/A

Frequently Asked Questions

What product was recalled?
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292. Recalled by Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.. Units affected: 4,923,471.
Why was this product recalled?
Sterility of Ultrasound gel can not be guaranteed.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 31, 2024. Severity: Moderate. Recall number: Z-0777-2024.