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MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENT
Recalled August 9, 2023 · FDA recall Z-2315-2023 · MEDLINE INDUSTRIES, LP - Northfield
Hazard
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. · FDA Class II
Units
6,939 kits
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Description
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL CATHETER INSERTION TRAY, Model Number: CVI680C; b. CVC INSERTION ACCESSORY KIT, Model Number: ECVC7880; c. CVL INSERTION TRAY, Model Number: DYNDC1786A; d. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635B; e. USG PIV INSERTION KIT, Model Number: DYNDV2480A;
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →