FDA Device recall Z-0942-2018
INFINITY DUAL HEMO MCable Pod
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of INFINITY DUAL HEMO MCable Pod by Draegar Medical Systems, citing dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0942-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-04 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Draegar Medical Systems |
| Distribution | n/a |
Product
INFINITY DUAL HEMO MCable Pod
Reason
Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger 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.
Identifiers
| code_info | Have the affected revision indexes: 15 or 16 (found on the product label) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0942-2018%22
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