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.
FDA Recall Z-1536-2015 · Posted 2015-04-27
Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeMEA
Date Initiated2014-04-17
Date Terminated2017-07-21
Product Quantity7,596 patient control modules
Reason for Recall
Potential for device malfunction resulting in flow when the device should not be flowing
Firm Action
Baxter Healthcare sent an Urgent Product Recall letter dated April 17, 2014, to the sole US consignee. The letter included instructions for the consignee to: 1) locate and remove all affected product; 2) contact Baxter's Center for Service to arrange for the return and credit; and 3) to complete and return the Customer Reply Form included with the recall notification. Questions about the recall can be answered by calling The Center for One Baxter at 800-422-9837.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.