Ambu Inc.: Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US

Hazard

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.

Details from the source

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. Quantity: 160 units Lot/code info: Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963

UPC codes

05707480156542

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.