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. 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;

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: CVI680C, UPC Number: 065316099294. b. Model Number: ECVC7880, UPC Number: 019532712961. c. Model Number: DYNDC1786A, UPC Number: 019348919911. d. Model Number: IVS3635B, UPC Number: 019348936055. e. Model Number: DYNDV2480A, UPC Number: 019532732721.

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