FDA-Device2023-08-09Class II
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;
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Affected count
9,017 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
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;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2339-2023Don't want to check this manually?
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