Recall Z-1482-2014
Hospira Inc. · initiated October 31, 2013
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: 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.
Reason for recall
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.
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-1482-2014
- Initiated
- October 31, 2013
- Posted by FDA
- May 1, 2014
- Terminated
- August 16, 2017
- Product code
- FRN – Pump, Infusion
- 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.
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1483-2014 Class I | Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including…Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it… | 10/31/2013Terminated |