The Recall Desk
ModerateFDA (Devices)·Z-1483-2014·Announced 2014-05-07

Hospira Acclaim Encore Infusion Pump Recall for Broken Door Assemblies

Hospira is recalling 13,218 Acclaim Encore infusion pumps because broken door assemblies may prevent proper closure, causing unrestricted flow or therapy delays.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences. The hazard involves a mechanical defect leading to therapy delays or unrestricted flow, without reported injuries or deaths, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Hospira Inc. is recalling 13,218 Hospira Acclaim Encore infusion pumps due to a defect in the door assemblies. The pumps are designed to deliver parenteral infusions, including whole blood or red blood cell components, and enteral fluids.

The recall is being issued because the door assemblies may break. If a 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 to facilities in 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. Users should check their pump serial numbers against the list provided in the official recall notice to determine if their device is affected.

The recalled product

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.
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: 12237
  • Serial Numbers: 12670196
  • 12670182
  • 12670203
  • 12670281
  • 12671061
  • 12671058
  • 12671175
  • 12718477
  • 12672450
  • 12672413
  • 12716099
  • 12716071
  • 12671563
  • 12672061
  • 12672079
  • 12672156
  • 12718948
  • 12717835
  • 12716259

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 · mechanical failure

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