Puritan Bennett 500 Series Ventilators recalled due to volatile organic compound release
Covidien recalls 34,642 Puritan Bennett 500 Series Ventilators due to release of volatile organic compound (2-propanol, 1,3-dichloro) from gas pathway components during prolonged use beyond 10 years.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this as a Class I recall, the agency's most serious medical device designation, which qualifies as Critical per the recall severity rubric. FDA Class I indicates substantial risk of harm.
Plain-English summary
Covidien is recalling Puritan Bennett 500 Series Ventilators, including models 560, 540, and 520. The recall affects approximately 34,642 units distributed throughout the United States and internationally. The FDA has classified this as a Class I recall, its most serious designation.
The devices are being recalled due to the release of a volatile organic compound (2-propanol, 1,3-dichloro) from components in the ventilator gas pathway. Although individual ventilators are labeled for a 10-year service life, continued use beyond this period—or cumulative use of multiple ventilators over more than 14 years total—may result in VOC exposure that poses a potential risk to health.
Facilities should identify affected devices using the REF identification numbers (4096600, 4097100, 4098300 and regional variants) or UDI-DI (GTIN) codes listed in the recall notice. Additional details are available in FDA recall notice Z-2446-2024 and from the manufacturer.
The recalled product
- Product
- Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02, PURITAN BENNETT 560 VENTILATOR APAC/4096600-03, Puritan Bennett 560…
- Manufacturer
- Covidien
- Affected units
- 34,642
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- PT00196729 A
- 2024-06-11
Distribution
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