Z-1723-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 14, 2025
- Initiation Date
- April 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160 units
Product Description
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.
Code Information
Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963