Device product

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

Z-0777-2024

June 09, 2023

Class II

Product summary

Firm: Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
Event: Event 93580
Status: Ongoing
Classification: Class II
Quantity: 4,923,471
Official record key: device-enforcement:Z-0777-2024

Official wording

Reason: Sterility of Ultrasound gel can not be guaranteed.

Code information: Lot Nos. SJ10091019 SJ22111019 SJ01041120 SJ25081020 SJ25061020 SJ20111020 SJ11021021 SJ24061021 SJ03061021 SJ14071021 SJ20091021 SJ09091021 SJ06022023 SJ10091019

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Sterility of Ultrasound gel can not be guaranteed.