Recall Z-1775-2022
Covidien Llc · initiated August 19, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Codes / lots: UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340
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.
FDA-determined cause: Process control
Action taken
Consignees were notified by letter delivered beginning August 19, 2022. Medtronic is advising that continued use of PB560 ventilators is appropriate when the actions listed in the recall letter are taken into consideration, unless this continued use is inconsistent with facility internal policies and procedures. All affected units require turbine replacement. Customers should contact Medtronic Service at 1-800-255-6774 to arrange for required service to replace the affected ventilator turbine component. If you have any questions regarding this communication, please contact your Medtronic representative or Technical Service at 1-800-255-6774.
Details
- Recall number
- Z-1775-2022
- Initiated
- August 19, 2022
- Posted by FDA
- September 22, 2022
- Product code
- QOS – Continuous Ventilator
- Quantity
- 5 US
- Distribution
- Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.
- Recalling firm
- Covidien Llc, Mansfield, MA