Reported Mar 21, 2018 · Terminated

INFINITY DUAL HEMO MCable Pod

Draegar Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Draegar Medical Systems, Inc. · 6 Tech Dr · Andover, MA · 01810-2434

Is this the product you have?

  • INFINITY DUAL HEMO MCable Pod
Lot codes and dates
  • Have the affected revision indexes15 or 16 (found on the product label)
Amount recalled
2,760

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 15, 2018 · Data as of Sep 19, 5:39 PM UTC

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