International Medical Devices Database

Manufacturer Address
Fisher & Paykel Healthcare, Ltd., 15 Maurice Paykel Place, East Tamaki, Auckland New Zealand
Source
USFDA
2 Events
- Recall of Device Recall Fisher and Paykel Healthcare CosyCot and Kit Replacement Head
- Recall of Infant Nasal CPAP

2 devices in the database

Device Recall Fisher and Paykel Healthcare CosyCot and Kit Replacement Head

Model / Serial
Affected Serial (SN) and Lot (LOT) Numbers Infant Warmers: 071116ZZZZZZ - 090810ZZZZZZ Spare Parts: 071116 - 090810
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
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.
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

Infant Nasal CPAP

Model / Serial
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.
Product Classification
Anesthesiology Devices
Device Class
1
Implanted device?
No
Distribution
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
Product Description
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.

One manufacturer with a similar name

Learn more about the data here

Fisher & Paykel Healthcare, Ltd.

Manufacturer Address
Fisher & Paykel Healthcare, Ltd., 15 Marcel Place, East Tamaki, North Shore City New Zealand
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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