Device product
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Z-1723-2025
Product summary
- Firm
- Ambu Inc.
- Event
- Event 96649
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 160 units
- Official record key
device-enforcement:Z-1723-2025
Official wording
Reason: Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.
Code information: Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963
Distribution pattern: US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.
Derived failure modes
-
Labeling or packaging
Incorrect labeling