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Medical Device Alert MDA/2019/032Issued: 03 October 2019 at 11:00Breathing circuit swivel elbow recall due to risk of cracks forming before or during summary Manufactured by Intersurgical, used in

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How to fill out breathing circuit swivel elbowrecall

01

Ensure the breathing circuit swivel elbowrecall is disconnected from the ventilator.

02

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03

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04

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Who needs breathing circuit swivel elbowrecall?

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Patients who require mechanical ventilation or respiratory support may need a breathing circuit swivel elbowrecall.

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What is breathing circuit swivel elbow recall?

Breathing circuit swivel elbow recall refers to the notification and corrective actions regarding the potential defects or safety concerns associated with the swivel elbows used in medical breathing circuits.

Who is required to file breathing circuit swivel elbow recall?

Manufacturers, importers, and distributors of breathing circuit swivel elbows are required to file the recall.

How to fill out breathing circuit swivel elbow recall?

To fill out a breathing circuit swivel elbow recall, one needs to provide details such as product identification, defects, distribution information, and corrective action plan in the designated recall form provided by regulatory authorities.

What is the purpose of breathing circuit swivel elbow recall?

The purpose of the recall is to ensure patient safety by removing potentially defective products from the market and preventing harm associated with their use.

What information must be reported on breathing circuit swivel elbow recall?

The report must include product details, defect descriptions, distribution lists, risk assessments, and proposed corrective actions.

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