Device product
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
Z-2536-2023
Product summary
- Event
- Event 92735
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 460 units
- Official record key
device-enforcement:Z-2536-2023
Official wording
Reason: Ultrasound gel mislabeled with inappropriate use.
Code information: a) 28-EG103, Lot Numbers: 10717C1190; b) 28-EG125, Lot Numbers: 30552C3318; c) 28-EG135, Lot Numbers: 10634C1175, 220221C2163; d) 28-EG151, Lot Numbers: 20655C2250, 20814C2279; e) 28-EG161, Lot Numbers: 10759C1198; f) 28-EG163, Lot Numbers: 10614C1166; g) 28-EG197, Lot Numbers: 10710C1190, 20804C2274;
Distribution pattern: US, Canada, UK, Panama, Netherlands
Derived failure modes
-
Labeling or packaging
mislabeled