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. C V MINOR PACK, Model Number: DYNJ64862A; b. DBD-C SECTION ADM, Model Number: DYKL1816; c. FETAL SURGERY, Model Number: DYNJ908118A;

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: DYNJ64862A, UPC Number: 019348942033. b. Model Number: DYKL1816, UPC Number: 019532705432. c. Model Number: DYNJ908118A, UPC Number: 019532730349.
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