Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB BASIN PACK, Model Number: DYNJ69864A; b. DELNOR VASCULAR BASIN PACK, Model Number: DYNJ82257; c. FLAP PACK, Model Number: DYNJ60224C;

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: DYNJ69864A, UPC Number: 019532713205. b. Model Number: DYNJ82257, UPC Number: 019532718165. c. Model Number: DYNJ60224C, UPC Number: 019532715184.

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