CLASS I Device recall · Reported 9 Jan 2013 · FDA Enforcement Report
reusable breathing circuit recalled by Fisher & Paykel Healthcare
Fisher & Paykel Healthcare is recalling reusable breathing circuit, distributed in Arkansas, Georgia, Illinois, Indiana. The recall was initiated on 19 Nov 2012 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0621-2013
- FDA event ID
- 63794
- Recalling firm
- Fisher & Paykel Healthcare, North Shore City, N/A
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Nov 2012
- FDA classified
- 3 Jan 2013
- Reported
- 9 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 19 Nov 2012 | Recall initiated by company | |
| 3 Jan 2013 | Classified by FDA | +45 days |
| 9 Jan 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. 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, which may lead to a loss of pressure for the int
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Where it was distributed
Worldwide Distribution - USA including IL, IN, AR and GA.
Questions about this recall
Why was it recalled?
FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. 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, which may lead to a loss of pressure for the int
Which lots are affected?
Lots 110810 and 111020
Where was it sold?
Worldwide Distribution - USA including IL, IN, AR and GA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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