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. ART LINE KIT ICH OR, Model Number: ART900; b. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570; c. ARTERIAL BUNDLE NO CATHETER, Model Number: ART995; d. ARTERIAL LINE INSERTION KIT, Model Number: ART775B; e. ARTERIAL LINE KIT W/O CATHETER, Model Number: ART890A; f. ARTERIAL LINE START KIT, Model Number: ART1160; g. ARTERIAL LINE START KIT W/O CATH, Model Number: P42453; h. ARTERIAL LINE TRAY W/O CATHETER, Model Number: ART1180; i. RADIAL ARTERIAL LINE KIT, Model Number: ART1070A

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: ART900; UPC Number: 10653160342540. b. Model Number: DT22570; UPC Number: 10653160343851. c. Model Number: ART995; UPC Number: 10193489190502. d. Model Number: ART775B; UPC Number: 10653160353560. e. Model Number: ART890A; UPC Number: 10653160356677. f. Model Number: ART1160; UPC Number: 10653160355762. g. Model Number: P42453; UPC Number: 10653160323792. h. Model Number: ART1180; UPC Number: 10653160355472. i. Model Number: ART1070A. UPC Number: 10653160358329.
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