FDA recall Z-2569-2021

Product

BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F

Reason for recall

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

Distribution

Domestic distribution nationwide. Product also distributed globally.

Key facts

Status

Terminated

Initiation date

2021-08-16

Report date

2021-10-06

Termination date

2024-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2569-2021