FDAFDA · Food and drugs·Recall number Z-0621-2013
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Published January 9, 2013 · Recall initiated: November 19, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Fisher & Paykel Healthcare, Ltd.
- Distributor
- Worldwide Distribution - USA including IL, IN, AR and GA.
- Lot
- Lots 110810 and 111020
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- New Zealand
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