MEDLINE INDUSTRIES, LP - Northfield: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967F; b. ENDOVENOUS AB

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: 6,733 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: DYNJ46967F, UPC Number: 019348957604. b. Model Number: DYNJ64059, UPC Number: 019348978270. c. Model Number: DYNJ62557, UPC Number: 019348966915. d. Model Number: TVS4000K, UPC Number: 081698202386.

UPC codes

019348957604, 019348978270, 019348966915, 081698202386

Source

Official record: FDA (Device enforcement) ↗

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