The Recall Desk
HighFDA (Devices)·Z-0621-2013·Announced 2013-01-09

Fisher & Paykel Healthcare Recalls Reusable Breathing Circuits Due to Hole Damage

Fisher & Paykel Healthcare is recalling specific lots of reusable breathing circuits because tube hole damage could cause gas leaks and loss of pressure during oxygen therapy.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a defect could lead to a loss of pressure for an intubated patient, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Fisher & Paykel Healthcare, Ltd. is recalling certain lots of reusable breathing circuits. The affected products are non-heated breathing circuits, 1.8m or 6 feet in length, used as an oxygen therapy delivery system for adult patients. The specific lot numbers involved are 110810 and 111020.

The recall was initiated because the manufacturer became aware that one batch of tubes supplied to them may contain hole damage. These tubes were incorporated into the 900MR068 reusable circuits. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system. This may lead to a loss of pressure for the intubated patient.

A total of 200 units were distributed worldwide, with 26 units distributed in the United States. The US distribution included Illinois, Indiana, Arkansas, and Georgia. The source text does not specify further instructions for consumers or healthcare providers regarding the immediate handling of these devices.

The recalled product

Product
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Manufacturer
Fisher & Paykel Healthcare, Ltd.
Category
Medical Device — Breathing Circuits
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lots 110810 and 111020

Distribution

Distributed in 4 states:

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