Recall Z-0942-2018 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draegar Medical Systems, Inc.
INFINITY DUAL HEMO MCable Pod
| Date | Oct 4, 2017 |
| Status | Terminated |
| Reason | Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Drger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure. |
| Root cause | Nonconforming Material/Component |
| Action | In September of 2017 an Urgent medical Device Recall letter was issued to customers informing them of the recall and to request that inventory be checked to see if the product subject in the recall is on the premises. To do this, the customer will check the label for the revision index number which is located on the upper middle portion of label. RI number 15 and 16 are included in the recall. No other numbers are subject to recall. Affected product will receive a sleeve from the company to correct the issue. Questions or concerns can be directed to 1-800-437-2437 (Press 1, then press 32349) o |
| Quantity | 2,760 |
| Distribution | Nationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113798 | INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET Draeger Medical Systems, Inc., Mar 22, 2012 |