FDA recall Z-1775-2022

Product

Puritan Bennett 560 Ventilator, PB560, CFN 4096600

Reason for recall

Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.

Distribution

Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.

Key facts

Status

Ongoing

Initiation date

2022-08-19

Report date

2022-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1775-2022