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Covidien, LP Recall 88987

Description: Puritan Bennett 980 Series Ventilator, 980X1ENNISB

Covidien, LP Recall 88987 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0348-2022
Event ID88987
Event DescriptionPuritan Bennett 980 Series Ventilator, 980X1ENNISB
Product TypeDevices
DistributionWorldwide distribution - US Nationwide.
Quantity278 total
Recall ReasonManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Device Classification20211215
Device Code InfoGTIN/UDI - 10884521171749 Serial Numbers: 35B1700430 35B1700442 35B1700456 35B1700510 35B1700514 35B1700520 35B1700553 35B1700554 35B1700559 35B1700561 35B1700608
Center Classification Date20211209
Recall Initiation Date20211104
Recalling FirmCovidien, LP
Initial Notification Letter
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