Recall Z-1536-2015 ยท MEA Pump, Infusion, Pca
Baxter Healthcare Corp.
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.
| Date | Apr 27, 2015 (initiated Apr 17, 2014) |
| Status | Terminated |
| Reason | Potential for device malfunction resulting in flow when the device should not be flowing |
| Root cause | Process control |
| 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. |
| Quantity | 7,596 patient control modules |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051253 | MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) Baxter Healthcare Corp, Jul 15, 2005 |