# FDA recall Z-0942-2018

> **Draegar Medical Systems, Inc.** · Class II · device recall initiated 2017-10-04.

## 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.

## Distribution

Nationally

## Key facts

- **Recall number:** Z-0942-2018
- **Recalling firm:** Draegar Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-04
- **Report date:** 2018-03-21
- **Termination date:** 2018-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0942-2018

## Citation

> AI Analytics. FDA recall Z-0942-2018. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-0942-2018. Source: US FDA. Licensed CC0.

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