BEUDAMED
    FDA Enforcement Class I Terminated

    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.

    Recall: Z-1539-2014 · Reported May 28, 2014

    Enforcement

    Recall Number
    Z-1539-2014
    Event ID
    68011
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fisher & Paykel Healthcare, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 28, 2014
    Initiation Date
    April 15, 2014
    Classification Date
    May 20, 2014
    Termination Date
    September 30, 2014
    Address
    15 Maurice Paykel Place, East Tamaki, Auckland, N/A, N/A, New Zealand

    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

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

    Code Info

    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.

    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

    Quantity

    62,063 units total (14,420 units USA)