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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE STERILE ULTRASOUND GEL

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 Class 2 Device Recall MEDLINE STERILE ULTRASOUND GELsee related information
Date Initiated by FirmJune 09, 2023
Date PostedJanuary 20, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0777-2024
Recall Event ID 93580
510(K)NumberK130581 
Product Classification Media, coupling, ultrasound - Product Code MUI
ProductREF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
Code Information Lot Nos. SJ10091019 SJ22111019 SJ01041120 SJ25081020 SJ25061020 SJ20111020 SJ11021021 SJ24061021 SJ03061021 SJ14071021 SJ20091021 SJ09091021 SJ06022023 SJ10091019
Recalling Firm/
Manufacturer		 Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
Akcaburgaz Mahallesi
Muhsin Yazicioglu Caddesi No:45/5
Esenyurt Turkey
For Additional Information ContactSecil Pala
212-428 68 48
Manufacturer Reason
for Recall		Sterility of Ultrasound gel can not be guaranteed.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 secil.pala@turkuazsaglik.com.tr .
Quantity in Commerce4,923,471
DistributionUS distribution to: Illinois and OUS (foreign) distribution to: Hong Kong
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MUI
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