Home / Recalls / Fisher & Paykel Healthcare, Ltd. / Z-0210-2015

Z-0210-2015 Class II Terminated

Recalled by Fisher & Paykel Healthcare, Ltd. — Auckland

Recall Details

Product Type
Devices
Report Date
November 19, 2014
Initiation Date
November 6, 2014
Termination Date
April 27, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Nationwide (U.S.): 661 Infant Warmers and 180 Spare Parts, Internationally: 2,451 Infant Warmers and 280 Spare Parts

Product Description

Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric intensive care units. Infant Warmers Model Number (REF) IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, IW990XXX Spare Parts Model Number (REF) 043041129, 043041130, 043041131, 043042359, 648040142

Reason for Recall

Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. There is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Bekgium, Bermuda, Chile, China, Croatia, Dominican Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Mexico. Morocco, New Zealand, Nigeria, Northern Ireland, Norway, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, singapore, Slovenia, South Africa, Spain, Sri Lanka, Sultanate of Oman, Syria, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam, and West Bank.

Code Information

Affected Serial (SN) and Lot (LOT) Numbers Infant Warmers: 071116ZZZZZZ - 090810ZZZZZZ Spare Parts: 071116 - 090810

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  • Z-1823-2024 Class II — Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US (April 2, 2024)
  • Z-1539-2014 Class I — Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Pr (April 15, 2014)
  • Z-1437-2013 Class II — Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). (April 22, 2013)
  • Z-0621-2013 Class I — Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing cir (November 19, 2012)