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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Event Detail

Event ID 63794
Product Type Devices
Status Ongoing
Recalling Firm Fisher & Paykel Healthcare, Ltd.
City North Shore City
Country NZ
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-19
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - USA including IL, IN, AR and GA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient. Lots 110810 and 111020 Class I FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy. 200 units total, 26 units US Z-0621-2013