Baxter Healthcare Corp. recalls The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of…

Recall date

April 17, 2014

Source

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

Recall number

Z-1536-2015

FDA classification

Class II

Brand / firm

Baxter Healthcare Corp.

Sold / distributed

Worldwide Distribution - US Distribution to the state of FL., and to the countries of : Belgium, Denmark, Germany, Italy, Japan, Norway, Poland, South Korea, Spain, Sweden and United Arab Emirates.

Why it was recalled

Potential for device malfunction resulting in flow when the device should not be flowing

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

What was recalled

The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.