Puritan Bennett 560 Ventilator recall
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Why was Puritan Bennett 560 Ventilator recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340
- Product
- Puritan Bennett 560 Ventilator, PB560, CFN 4096600
- Recalling firm
- Covidien Llc
- Quantity
- 5 US
- Distribution
- Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.
- Recall date
- September 28, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)