Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC INFANT INSERTION PACK, Model Number: CVI4770A; b. INSERTION BUNDLE, Model Number: DT21275; c. MIDLINE DRESSING CHANGE KIT, Model Number: EBSI1464; d. MIDLINE INSERTION KIT, Model Number: DT20155; e. PICC LINE DRESSING TRAY, Model Number: DT22045; f. UNIVERSAL DRESSING PPE KIT, Model Number: DT22065; g. UNIVERSAL DRESSING & PPE KIT, Model Number: DT22065; h. VA MAINTENANCE PACK, Model Number: EBSI1382;

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

Code information: All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: CVI4770A, UPC Number: 10653160350828. b. Model Number: DT21275, UPC Number: 10653160318934. c. Model Number: EBSI1464, UPC Number: 10193489198959. d. Model Number: DT20155, UPC Number: 10653160290070. e. Model Number: DT22045, UPC Number: 10653160325659. f. Model Number: DT22065, UPC Number: 065316032660. g. Model Number: DT22065, UPC Number: 10653160326601. h. Model Number: EBSI1382, UPC Number: 10193489196269.

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.