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. ANESTHESIA CVL KIT-LF, Model Number: DYNJ52283C; b. ANESTHESIA OH TOTE, Model Number: DYNJ61476;

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: DYNJ52283C; UPC Number: 019348965000. b. Model Number: DYNJ61476; UPC Number: 019348957199.
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