Draegar Medical Systems, Inc. recalls INFINITY DUAL HEMO MCable Pod

Recall date

October 4, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0942-2018

FDA classification

Class II

Brand / firm

Draegar Medical Systems, Inc.

Sold / distributed

Nationally

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

INFINITY DUAL HEMO MCable Pod