MEDLINE INDUSTRIES, LP - Northfield: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL CATHETER INSERTION TRAY, Model Number: CVI68

Hazard

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

Details from the source

Reason for recall: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates. Quantity: 6,939 kits 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.

UPC codes

065316099294, 019532712961, 019348919911, 019348936055, 019532732721

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.