Recall Z-2958-2011 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through cl
| Date | Aug 8, 2011 (initiated Jul 22, 2011) |
| Status | Terminated |
| Reason | Baxter's Service Center tested and returned to the user the Colleague infusion pump that did not meet PSIG (Pounds-force per Square Inch) specifications |
| Root cause | Other |
| Action | Baxter Healthcare Corp. notified the consignee by telephoned on July 22, 2011, with the call documented per the approved call script. A follow-up "URGENT PRODUCT RECALL" notification was sent dated July 25, 2011, reiterating the telephone communication informing them that the COLLEAGUE pump may not have met certain PSIG (Pounds-force per Square Inch) specifications after testing by the Baxter Global Technical Service Center. Both forms of notification identified the affected product, problem description, hazard involved, and actions needed to be taken. The consignee was instructed to locate |
| Quantity | 1 unit |
| Distribution | (USA) Nationwide Distribution including the state of Minnesota. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063696 | COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 Baxterhealthcare, Inc., Feb 27, 2007 |