Covidien, LP Recall 88987
Description: Puritan Bennett 980 Series Ventilator, 980A1ENNISB
Covidien, LP Recall 88987 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0338-2022 |
Event ID | 88987 |
Event Description | Puritan Bennett 980 Series Ventilator, 980A1ENNISB |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide. |
Quantity | 278 total |
Recall Reason | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
Device Classification | 20211215 |
Device Code Info | GTIN/UDI - 10884521201897 Serial Numbers: 35B1700507, 35B1700533, 35B1700539, 35B1700465, 35B1700580, 35B1700530, 35B17005363, 5B1700542, 35B1700509, 35B1701614, 35B1700527, 35B1700537, 35B1700541, 35B1700508 & 35B1701569. |
Center Classification Date | 20211209 |
Recall Initiation Date | 20211104 |
Recalling Firm | Covidien, LP |
Initial Notification | Letter |
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