Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
- Company
- Ambu Inc.
- Recall Initiated
- April 7, 2025
- Posted
- May 6, 2025
- Recall Number
- Z-1723-2025
- Quantity
- 160 units
- Firm Location
- Columbia, MD
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
US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.
Lot / Code Info
Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963
Root Cause
Process control
Action Taken
Ambu notified sales representative first on 04/07/2025 with an "Urgent Field Safety Notice" letter and they are instructed to visit the affected accounts to notify them of the recall. The letter instructs customers to identify and quarantine any affected units on hand, to arrange for the return of affected units or destroy them on site, and to complete and return the response form.