FDAOctober 4, 2017device

INFINITY DUAL HEMO MCable Pod

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

draegar medical systemsdraegardraegar medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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