Device product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V MINOR PACK, Model Number: DYNJ64862A; b. DBD-C SECTION ADM, Model Number: DYKL1816; c. FETAL SURGERY, Model Number: DYNJ908118A;
Z-2334-2023
Product summary
- Event
- Event 92399
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 371 kits
- Official record key
device-enforcement:Z-2334-2023
Official wording
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: DYNJ64862A, UPC Number: 019348942033. b. Model Number: DYKL1816, UPC Number: 019532705432. c. Model Number: DYNJ908118A, UPC Number: 019532730349.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Derived failure modes
-
Unknown
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.