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 |
| 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. |
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 |
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