Home / Recalls / Medical Devices
Fisher & Paykel Healthcare, Ltd. recalls Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxyge
Recalled January 9, 2013 · FDA recall Z-0621-2013 · Fisher & Paykel Healthcare
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 · FDA Class I
Units
200 units total, 26 units US
Sold at
Worldwide Distribution - USA including IL, IN, AR and GA.
Description
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
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(s)
Fisher & Paykel Healthcare, Ltd.
Made in
New Zealand
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →