Fisher & Paykel Healthcare, Ltd.

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

General Hospital and Personal Use Devices

2

No

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.

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

Nasal CPAP Prongs (10 pack), Lot Numbers 13060603XX through 14032503XX; 13082003XX through 14032503XX; 13091903XX through 14032503XX; 13082603XX through 14032503XX; 13091903XX through 14032503XX; 14022603XX through 14032503XX; 14022603XX through 14032503XX; 14031203XX through 14032503XX; 14031203XX through 14032503XX; 14031203XX through 14032503XX; 14031203XX through 14032503XX. Bubble CPAP Starter Kits, Lot Numbers 131007 through 140325.

Anesthesiology Devices

1

No

Worldwide Distribution - USA (nationwide) and Internationally to: ARGENTINA AUSTRALIA BANGLADESH BELGIUM CANADA CHILE CHINA FRANCE GERMANY GREAT BRITAIN GREECE HUNGARY INDIA INDONESIA IRAQ ISRAEL ITALY JAPAN LIBYA MALAYSIA NEPAL NETHERLANDS NEW ZEALAND PERU POLAND PORTUGAL QATAR ROMANIA RUSSIA RWANDA SAUDI ARABIA SOUTH AFRICA SPAIN SRI LANKA SWITZERLAND TAIWAN THAILAND TRINIDAD & TOBAGO TURKEY UNITED ARAB EMIRATES

Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. || CPAP Prongs (10 pack): || Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. || Bubble CPAP Starter Kits: || Model No. BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK. || The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface.