Recall Z-0777-2024— Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.

Name: FDA recall Z-0777-2024
Creator: U.S. Food and Drug Administration
Published: 2023-06-09

Class II · Ongoing

Class II FDA medical device recall by Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S., initiated 2023-06-09. It names one FDA 510(k) clearance: K130581. Product: REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292. Reason: Sterility of Ultrasound gel can not be guaranteed..

Recalling firm: Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
Classification: Class II
Status: Ongoing
Initiated: 2023-06-09
Firm location: Esenyurt, N/A, Turkey

510(k) clearances named in this recall

1 on FDA's record

K130581 — KONIX STERILE GELTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa·cleared 2014-06-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.