Enforcement Report - Week of March 20, 2013
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Product Detail
| Product Description | Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system. |
|---|---|
| Recall Number | Z-0939-2013 |
| Classification | Class II |
| Code Info | Catalog Number MS20783 (Infinity MCable-Dual Hemo) |
| Product Distributed Qty | 260 |
| Reason For Recall | The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed. |
Event Detail
| Event Id | 64447 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Draeger Medical, Inc. |
| City | Telford |
| State | PA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-13 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Distributed in the states of CA, IL, and MA. |
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