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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 Ventilator LATAM/4096600-04, Puritan Bennett 560 Ventilator EMEA/4096600-05, Puritan Bennett 560 Ventilator CAN ANZ/4096600-06, Puritan Bennett 540 Ventilator USA/4097100 Puritan Bennett 520 Ventilator/4098300, Puritan Bennett 520 Ventilator EU-DIV/4098300-01, Puritan Bennett 520 Ventilator Japan/4098300-02, Puritan Bennett 520 Ventilator APAC/4098300-03, Puritan Bennett 520 Ventilator EMEA/4098300-05, Puritan Bennett 520 Ventilator CAN/ANZ/4098300-06, DL4096600 DL PB560 VENTILATOR/DL4096600, DL4096600-06 RFB PB560 VENT CAN ANZ/DL4096600-06, REFURBISHED PB540 VENTILATOR/DL4097100, Puritan Bennett 540 Ventilator Refurbished/DS4097100

Lot codes and dates: REF/UDI-DI(GTIN)
4096600/10884521087798
4096600-01/10884521195998
4096600-02/10884521196001
4096600-03/10884521196018
4096600-04/10884521196025
4096600-05/10884521196032
4096600-06/10884521196377
4097100/4097100
4098300/10884521183636
4098300-01/10884521195943
4098300-02/4098300-02
4098300-03/10884521195967
4098300-05/10884521195981
4098300-06/10884521196384
DL4096600/10884521786509
DL4096600-06/10884521786516
DL4097100/DL4097100
DS4097100/DS4097100
All device serial numbers used before distribution of PB500 Series Ventilator User Manual and Clinician's Manual addendum, PT00196729 A, 2024-06-11
Amount recalled: 34,642

Where it was sold

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560…

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Where it was sold

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