medical Class II Updated 2023-08-09

MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Tu

Recalled Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; b. STD INSERTION/DIALYSIS INSERTION TRAY, Model Number: CVI3845;

Hazard / Issue

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: MNS10750A, UPC Number: 10653160356073. b. Model Number: CVI3845, UPC Number: 10653160270072.
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