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Z-1539-2014 Class I Terminated

Recalled by Fisher & Paykel Healthcare, Ltd. — Auckland, N/A

FDA device recall Z-1539-2014 was initiated by Fisher & Paykel Healthcare, Ltd. on April 15, 2014 and is designated Class I. Reason for recall: The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted. The recall status is terminated (terminated September 30, 2014). Affected quantity: 62,063 units total (14,420 units USA).

Recall Details

Product Type
Devices
Report Date
May 28, 2014
Initiation Date
April 15, 2014
Termination Date
September 30, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
62,063 units total (14,420 units USA)

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.

Reason for Recall

The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.

Distribution Pattern

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

Code Information

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.

Other recalls by Fisher & Paykel Healthcare, Ltd.

  • Z-0158-2026 Class II — Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit U (September 18, 2025)
  • Z-3262-2024 Class II — PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1 (August 7, 2024)
  • Z-1823-2024 Class II — Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US (April 2, 2024)
  • Z-0210-2015 Class II — Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Payk (November 6, 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)

FDA data resources