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Covidien, LP Recall 88987

Description: Puritan Bennett 980 Series Ventilator, 980A1ENNISB

Covidien, LP Recall 88987 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0338-2022
Event ID88987
Event DescriptionPuritan Bennett 980 Series Ventilator, 980A1ENNISB
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 - 10884521201897 Serial Numbers: 35B1700507, 35B1700533, 35B1700539, 35B1700465, 35B1700580, 35B1700530, 35B17005363, 5B1700542, 35B1700509, 35B1701614, 35B1700527, 35B1700537, 35B1700541, 35B1700508 & 35B1701569.
Center Classification Date20211209
Recall Initiation Date20211104
Recalling FirmCovidien, LP
Initial Notification Letter
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