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Covidien, LP Recall 88987

Description: Puritan Bennett 980 Series Ventilator, 980U1ENASAA

Covidien, LP Recall 88987 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0342-2022
Event ID88987
Event DescriptionPuritan Bennett 980 Series Ventilator, 980U1ENASAA
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 - 10884521201385 Serial Numbers: 35B1700252 35B1700365 35B1700399 35B1700407 35B1700489 35B1700505 35B1700513 35B1700555 35B1700557 35B1700562 35B1700563 35B1700565 35B1700566 35B1700605 35B1700612 35B1700634 35B1700651 35B1700662 35B1700663
Center Classification Date20211209
Recall Initiation Date20211104
Recalling FirmCovidien, LP
Initial Notification Letter
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