—#125797

Product

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K991501
Affected lot / code info: List Number: 12032; Serial Numbers: 12322921, 12323859, 12322780, 12322801, 12322810, 12322812, 12322878, 12322880, 12322887, 12322896, 12322903, 12322904, 12322911, 12322917, 12322936, 12322939, 12323867, 12322916, 12323056, 12321139, 12324767, 12324854, 12324802, 12322873, 12324375, 1231453, 1231610.

Why it was recalled

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 (FDA determination)

Component design/selection

Action the firm took

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 reply form and return it to the fax number or e-mail address on the form. Customers are to contact Stericycle at 866-891-0586 (Monday - Friday, 8:00 AM - 5:00 PM ET) to obtain additional reply forms if needed. If the devices were further distributed, those customers should be notified and asked to contact Stericycle at 866-891-0586 (Monday - Friday, 8:00 AM - 5:00 PM ET) to receive a reply form. The letter reminds customers that Hospira is retiring the Acclaim Encore infusion pump and will no longer support them as of December 31, 2014.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-10-31
Posted by FDA: 2014-05-01
Terminated: 2017-08-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125797. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.