Covidien, LP Recall 88987
Description: Puritan Bennett 980 Series Ventilator, 980U1ENASAA
Covidien, LP Recall 88987 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0342-2022 |
| Event ID | 88987 |
| Event Description | Puritan Bennett 980 Series Ventilator, 980U1ENASAA |
| 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 - 10884521201385 Serial Numbers: 35B1700252 35B1700365 35B1700399 35B1700407 35B1700489 35B1700505 35B1700513 35B1700555 35B1700557 35B1700562 35B1700563 35B1700565 35B1700566 35B1700605 35B1700612 35B1700634 35B1700651 35B1700662 35B1700663 |
| Center Classification Date | 20211209 |
| Recall Initiation Date | 20211104 |
| Recalling Firm | Covidien, LP |
| Initial Notification | Letter |
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