Enforcement Report - Week of January 9, 2013
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Product Detail
| Product Description | Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient. |
|---|---|
| Recall Number | Z-0621-2013 |
| Classification | Class I |
| Code Info | Lots 110810 and 111020 |
| Product Distributed Qty | 200 units total, 26 units US |
| Reason For Recall | 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. |
Event Detail
| Event Id | 63794 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Fisher & Paykel Healthcare, Ltd. |
| City | North Shore City |
| State | 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. |
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