Puritan Bennett 560 ventilators used for more than 14 years of cumulative service may release harmful VOCs. Owners should check if their device was sold before June 2024 with specific serial numbers.
Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than 14 years of cumulative duration may pose harm to health due to a volatile organic compound (VOC), 2-propanol, 1,3-dichloro released from some components in the ventilator gas pathway
Puritan Bennett 560 ventilators that have been used for more than 14 years of cumulative service may pose health risks due to harmful chemicals released from the device. This recall affects ventilators sold before June 2024 with specific serial numbers.
These ventilators can release harmful volatile organic compounds (VOCs) like 2-propanol and 1,3-dichloro when used for more than 14 years of cumulative service. The chemicals may cause health issues over time, especially with prolonged use.
Healthcare providers using Puritan Bennett 560 ventilators for long-term patient care are most at risk. Patients receiving ventilator support for extended periods may be affected if the device has been used beyond the 14-year cumulative limit.
Check if your ventilator has a serial number from the list provided in the recall notice. Devices sold before June 2024 with specific regional model numbers (e.g., PB560, PB540, PB520) are affected.
Look for the serial number on your ventilator's label or documentation to confirm if it matches the list of affected models and serial numbers in the recall notice.
Determine how long your ventilator has been in use, including cumulative service time across multiple devices, to see if it exceeds 14 years.
No, the recall does not require immediate discontinuation. However, you should check if your ventilator meets the criteria for the recall and review its cumulative service duration.
If your ventilator has been used for more than 14 years of cumulative service, it may release harmful chemicals. You should contact the manufacturer for guidance on safe alternatives.
Check your ventilator's serial number against the list of affected models and serial numbers provided in the recall notice, which includes devices sold before June 2024.
We’ve drafted a message you can send Puritan Bennett to request your refund or repair — edit it as you like.
Subject: Recall Z-2446-2024 — Puritan Bennett Puritan Bennett Hello, I own a Puritan Bennett that is covered by recall Z-2446-2024 from Puritan Bennett. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
