FDA-Device2015-05-06Class II
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.
Baxter Healthcare Corp.
Hazard
Potential for device malfunction resulting in flow when the device should not be flowing
Sold states
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.
Affected count
7,596 patient control modules
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1536-2015Don't want to check this manually?
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