Recall Z-1775-2022— Covidien Llc
Class II · Ongoing
Class II FDA medical device recall by Covidien Llc, initiated 2022-08-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Puritan Bennett 560 Ventilator, PB560, CFN 4096600. Reason: 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..
- Recalling firm
- Covidien Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-08-19
- Firm location
- Mansfield, MA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.