Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. BREAST BIOPSY KIT, Model Number: DYNDA1224A, DYNDA1224B; b. BREAST BIOPSY TRAY, Model Number: SPEC0130C; c. BREAST IMAGING TRAY, Model Number: MNS11895; d. ULTRASOUND BREAST BIOPSY, Model Number: DYNDH1496; e. ULTRASOUND GUIDE BREAST BIOPSY, Model Number: DYNDH1319; f. US BREAST BIOPSY TRAY, Model Number: DYNDH1187A;

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: DYNDA1224A, UPC Number: 10888277985643; Model Number: DYNDA1224B, UPC Number: 10193489191448. b. Model Number: SPEC0130C, UPC Number: 10193489196641. c. Model Number: MNS11895, UPC Number: 10653160324645. d. Model Number: DYNDH1496, UPC Number: 10193489193947. e. Model Number: DYNDH1319, UPC Number: 10889942795475. f. Model Number: DYNDH1187A, UPC Number: 10889942702633.

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