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FDA (Device enforcement)Recalled 2021-11-04closedclass i

Covidien Llc: Puritan Bennett 980 Series Ventilator, 980X3JADIJJ

Is my product affected?

Puritan Bennett 980 Series Ventilator, 980X3JADIJJ

  • UPC 10884521172531

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

What happened

Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing assembly error involving a capacitor. The error may cause the ventilator to become inoperable during use. The recalled ventilators were distributed worldwide, including throughout the United States, and are identified by serial numbers 35B1700393, 35B1700419, 35B1700420, 35B1700427, 35B1700428, 35B1700429, 35B1700540, 35B1700564, 35B1700568, 35B1700573, and 35B1800002.

The source document does not specify what action affected consumers should take in response to this recall.

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 - 10884521172531 Serial Numbers: 35B1700393 35B1700419 35B1700420 35B1700427 35B1700428 35B1700429 35B1700540 35B1700564 35B1700568 35B1700573 35B1800002

Source

Official record: FDA (Device enforcement) ↗

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

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