Device product
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Z-2534-2023
Product summary
- Event
- Event 92735
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26900 units
- Official record key
device-enforcement:Z-2534-2023
Official wording
Reason: Ultrasound gel mislabeled with inappropriate use.
Code information: a) 20-PMT03, Lot Numbers: 30479C3299 b) 20-PMT04, Lot Numbers: 30394C3279
Distribution pattern: US, Canada, UK, Panama, Netherlands
Derived failure modes
-
Labeling or packaging
mislabeled