Recall Z-1483-2014— Hospira Inc.

Name: FDA recall Z-1483-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-31

Class I · Terminated

Class I FDA medical device recall by Hospira Inc., initiated 2013-10-31, terminated 2017-08-16. It names one FDA 510(k) clearance: K011096. Product: Hospira Acclaim Encore 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.. Reason: 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..

Recalling firm: Hospira Inc.
Classification: Class I
Status: Terminated
Initiated: 2013-10-31
Terminated: 2017-08-16
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K011096 — ABBOTT ACCLAIM ENCORE, MODEL 12237Abbott Laboratories·cleared 2001-05-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Hospira Acclaim Encore 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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.