The Recall Desk
HighFDA (Devices)·Z-1482-2014·Announced 2014-05-07

Hospira Recalls Acclaim Infusion Pumps Due to Broken Door Assemblies

Hospira is recalling 13,218 Abbott Acclaim Infusion Pumps because broken door assemblies may prevent the door from closing, potentially causing unrestricted flow or therapy delays.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a mechanical failure could lead to unrestricted flow or therapy delays, representing a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Hospira Inc. is recalling 13,218 Abbott Acclaim Infusion Pumps, which are designed to deliver parenteral infusions and enteral fluids. The recall is due to customer reports of broken door assemblies on the devices.

If the door assembly breaks, it may prevent the door from closing properly, which could result in unrestricted flow. Additionally, if the door cannot be closed, the pump cannot be used, potentially resulting in a delay in therapy. The affected pumps were distributed nationwide across 48 states and the District of Columbia.

Healthcare facilities and consumers should stop using the affected pumps and contact Hospira for further instructions. The recall involves specific serial numbers listed in the official FDA notice.

The recalled product

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.
Manufacturer
Hospira Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
13,218

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • List Number: 12032
  • Serial Numbers: 12322921
  • 12323859
  • 12322780
  • 12322801
  • 12322810
  • 12322812
  • 12322878
  • 12322880
  • 12322887
  • 12322896
  • 12322903
  • 12322904
  • 12322911
  • 12322917
  • 12322936
  • 12322939
  • 12323867
  • 12322916
  • 12323056

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Hospira Inc.

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Same hazard · unrestricted flow

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