Device product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; b. STD INSERTION/DIALYSIS INSERTION TRAY, Model Number: CVI3845;
Z-2313-2023
Product summary
- Event
- Event 92399
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 135 kits
- Official record key
device-enforcement:Z-2313-2023
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: MNS10750A, UPC Number: 10653160356073. b. Model Number: CVI3845, UPC Number: 10653160270072.
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.