Covidien, LP Recall 88987
Description: Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
Covidien, LP Recall 88987 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0351-2022 |
Event ID | 88987 |
Event Description | Puritan Bennett 980 Series Ventilator, 980X2ESDIEC |
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 - 10884521174177 Serial Numbers: 35B1700627 35B1700628 35B1700629 35B1700630 35B1700631 35B1700632 |
Center Classification Date | 20211209 |
Recall Initiation Date | 20211104 |
Recalling Firm | Covidien, LP |
Initial Notification | Letter |
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