Device product
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
Z-2535-2023
Product summary
- Event
- Event 92735
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 117875 units
- Official record key
device-enforcement:Z-2535-2023
Official wording
Reason: Ultrasound gel mislabeled with inappropriate use.
Code information: a) 20-PC424, Lot Numbers: 21109C2345; b) 20-PC448, Lot Numbers: 30371C3276; c) 20-PC548, Lot Numbers: 21088C2341, 30353C3268; d) 20-PC596, Lot Numbers: 20622C2244, 30481C3301; e) 20-PC648, Lot Numbers: 20145C2088, 20163C2097
Distribution pattern: US, Canada, UK, Panama, Netherlands
Derived failure modes
-
Labeling or packaging
mislabeled