Device product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
Z-2294-2023
Product summary
- Event
- Event 92399
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 192 kits
- Official record key
device-enforcement:Z-2294-2023
Official wording
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Code information: Model Number: DYNJ45158A, UPC Number: 088827750721, all lot numbers distributed from Medline between 04/01/2020 and 04/28/2023.
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.