Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

INFINITY DUAL HEMO MCable Pod Recalled by Draegar Medical Systems, Inc. Due to Dual Hemo MCable Pods with Revision Index (RI)...

Date: October 4, 2017
Company: Draegar Medical Systems, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Draegar Medical Systems, Inc. directly.

Affected Products

INFINITY DUAL HEMO MCable Pod

Quantity: 2,760

Why Was This 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.

Where Was This Sold?

Nationally

About Draegar Medical Systems, Inc.

Draegar Medical Systems, Inc. has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report