medical Class I Updated 2021-12-15

Covidien Llc recalls Puritan Bennett 980 Series Ventilator, 980U1ENASAA

Recalled Product

Puritan Bennett 980 Series Ventilator, 980U1ENASAA


Hazard / Issue

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN/UDI - 10884521201385 Serial Numbers: 35B1700252 35B1700365 35B1700399 35B1700407 35B1700489 35B1700505 35B1700513 35B1700555 35B1700557 35B1700562 35B1700563 35B1700565 35B1700566 35B1700605 35B1700612 35B1700634 35B1700651 35B1700662 35B1700663
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