Class I Medical Device Recall: Hospira Inc., Abbott Acclaim Infusion Pumps and Hospira Acclaim Encore Infusion Pumps – Broken Door Assemblies May Result in Over

Recall Class: Class I

Date Recall Initiated: October 31, 2013

Products: Abbott Acclaim Infusion Pumps and Hospira Acclaim Encore Infusion Pumps, List Numbers 12032 and 12237

Affected Abbott Acclaim infusion pumps were manufactured from February 1998 to November 1998 and distributed from September 1998 through February 2004. Affected Hospira Acclaim Encore infusion pump were manufactured from February 1997 to February 2010 and distributed from July 1999 through November 2013.

Use: Depending on the clinical need, these infusion pumps are used to deliver parenteral infusions, including whole blood or red blood cell components, and enteral fluids, including various medicines and nutritional fluids. They are intended for use in hospitals, ambulatory nursing home (extended care) settings, or home care.

Recalling Firm:
Hospira, Inc.
275 N. Field Drive
Lake Forest, IL, 60045

Reason for Recall:

Hospira received customer reports of broken door assemblies on the Abbott Acclaim infusion pumps and the Hospira Acclaim Encore infusion pumps. When the door is closed properly, it helps ensure that the tubing is seated properly to ensure appropriate flow of therapy to the patient. If the door assembly breaks, it may prevent the door from closing properly and an over-infusion or a delay of therapy may occur. If the door cannot be closed, the pump cannot be used which can result in a delay of therapy.

Use of these affected products may cause serious adverse health consequences, including death.

Public Contact:

For further inquiries, please contact Hospira using the information provided below:

FDA District: Chicago District Office

More Information about this Recall: 

Hospira provided the following instructions for customers:

Due to the five (5) year expected life of the door assembly, Hospira recommends that users inspect
each Hospira/Abbott Acclaim Encore infusion pump for door handle cracks, prior to programming a
therapy, by following the steps outlined below:

1. After inserting the tubing (with the roller clamp closed) and closing the door handle against
   the infusion pump, check that the door is fully closed.
   1. If a pump has a door that does not close properly, and a gap or separation exists between the
      completely closed door and the pump itself, remove the pump from clinical service and call
      Hospira.
   2. For pumps where the door closes correctly, proceed to Step 2.
2. For pumps with the door closing correctly, and a gap or separation does not exist between the completely closed door and the pump itself, check that there is no free flow activity
   in the drip chamber of the administration set by opening the roller clamp.
   1. If free flow is detected, close the roller clamp, remove the pump from clinical service and call Hospira.
3. If no issues are found through steps 1 and 2, the pump is deemed acceptable for use.

Additionally, please take the following actions related to this safety notification:

1. Ensure that all potential users in your facility are made aware of this safety notification and
   the recommended actions.
2. Complete the attached reply form and return it to the fax number or e-mail address on the
   form, even if you do not have the affected product.

• Contact Stericycle at 1-866-891-0586 (M-F, 8am-5pm, ET) to obtain additional copies of the reply form, if needed.

Product Correction:

After following the instructions above, if you determine that a pump has a door that does not close
correctly or if free flow is detected while the administration set is in the pump with the door
closed, close the roller clamp, remove the pump from clinical service and call Hospira.

About Class I Recalls

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.