INFINITY DUAL HEMO MCable Pod — Class II medical device recall Z-0942-2018
Terminated recall by Draegar Medical Systems, Inc., reported 2018-03-21. Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care S
| Recall number | Z-0942-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draegar Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2017-10-04 |
| Classified | 2018-03-09 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2018-06-15 |
| Quantity | 2,760 |
Product
INFINITY DUAL HEMO MCable Pod
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0942-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.