Recall Z-1482-2014 ยท FRN Pump, Infusion
Hospira Inc.
Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
| Date | May 1, 2014 (initiated Oct 31, 2013) |
| Status | Terminated |
| Reason | Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy. |
| Root cause | Component design/selection |
| Action | URGENT MEDICAL DEVICE CORRECTION letters, dated October 31, 2013, were sent to all direct accounts. The letters identified the affected product, as well as the reason for recall, risk to health, and instructions for device users. Users are to inspect each Hospira/Abbott Acclaim Encore infusion pump for door handle cracks prior to programming a therapy by following the provided instructions. The letter also included instructions for recipients to ensure that all potential users in the facility are made aware of the safety notification and the recommended actions; and complete the attached re |
| Quantity | 13,218 infusion pumps total |
| Distribution | Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, CR, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991501 | ACCLAIM INFUSION PUMP Abbott Laboratories, May 13, 1999 |