FDA-Device2013-01-09Class I
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Fisher & Paykel Healthcare, Ltd.
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
Sold states
Worldwide Distribution - USA including IL, IN, AR and GA.
Affected count
200 units total, 26 units US
Manufactured in
15 Marcel Place, East Tamaki, North Shore City, N/A, New Zealand
Products
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0621-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief