Covidien Llc: Puritan Bennett 980 Series Ventilator, 980X1ENDIUU

Is my product affected?

Puritan Bennett 980 Series Ventilator, 980X1ENDIUU

• UPC 10884521171541

Check against the official notice below — it lists the full affected range.

What happened

Covidien LLC has recalled 278 Puritan Bennett 980X1ENDIUU ventilators distributed worldwide and throughout the United States. The recall was issued because of a manufacturing assembly error involving a capacitor inside the ventilator that was incorrectly assembled, which could cause the device to stop working during use.

The affected ventilators can be identified by their serial numbers, which range from 35B1700300 through 35B1703438 and 35B1800033 through 35B1800811. The product has a GTIN/UDI of 10884521171541. The recall record does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. Distribution: Worldwide distribution - US Nationwide. Quantity: 278 total Lot/code info: GTIN/UDI - 10884521171541 Serial Numbers: 35B1700300 35B1700306 35B1700307 35B1700362 35B1700372 35B1700384 35B1700387 35B1700388 35B1700396 35B1700397 35B1700403 35B1700413 35B1700416 35B1700418 35B1700426 35B1700431 35B1700434 35B1700440 35B1700445 35B1700451 35B1700452 35B1700453 35B1700459 35B1700461 35B1700464 35B1700468 35B1700472 35B1700477 35B1700478 35B1700479 35B1700480 35B1700484 35B1700485 35B1700494 35B1700495 35B1700496 35B1700501 35B1700502 35B1700503 35B1700504 35B1700534 35B1700574 35B1700579 35B1700604 35B1700609 35B1700638 35B1700655 35B1700664 35B1700816 35B1700919 35B1700994 35B1701001 35B1701418 35B1701698 35B1702832 35B1703438 35B1800033 35B1800721 35B1800811

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Puritan Bennett 980 Series Ventilator, 980A1ENNISB2021-11-04
• Puritan Bennett 980 Series Ventilator, 980S1ENDICU2021-11-04
• Puritan Bennett 980 Series Ventilator, 980S3ENDICU2021-11-04
• Puritan Bennett 980 Series Ventilator, 980U1ENASAA2021-11-04
• Puritan Bennett 980 Series Ventilator, 980X1ENNISB2021-11-04

All FDA (Device enforcement) recalls