Covidien, LP Recall 88987
Description: Puritan Bennett 980 Series Ventilator, 980X1ENNISB
Covidien, LP Recall 88987 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0348-2022 |
| Event ID | 88987 |
| Event Description | Puritan Bennett 980 Series Ventilator, 980X1ENNISB |
| 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 - 10884521171749 Serial Numbers: 35B1700430 35B1700442 35B1700456 35B1700510 35B1700514 35B1700520 35B1700553 35B1700554 35B1700559 35B1700561 35B1700608 |
| Center Classification Date | 20211209 |
| Recall Initiation Date | 20211104 |
| Recalling Firm | Covidien, LP |
| Initial Notification | Letter |
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