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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
Recalled May 6, 2015 · FDA recall Z-1536-2015 · Baxter Healthcare
Hazard
Potential for device malfunction resulting in flow when the device should not be flowing · FDA Class II
Units
7,596 patient control modules
Sold at
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.
Description
Potential for device malfunction resulting in flow when the device should not be flowing
Product
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.
Manufacturer(s)
Baxter Healthcare Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →