The Recall Desk
ModerateFDA (Devices)·Z-2873-2016·Announced 2016-09-28

Hospira LifeCare PCA Infusion System Recalled for Screw Rotation Error

Hospira Inc. is recalling 8,794 LifeCare PCA Infusion Systems because a screw rotation error can cause the pump to alarm and stop infusion.

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 II, and the source text describes a malfunction that causes the infusion to stop and alarm, but does not report any injuries, illnesses, or deaths.

Plain-English summary

Hospira Inc. is recalling 8,794 units of the LifeCare PCA Infusion System with Hospira MedNet Software. The recall covers devices distributed nationwide in the United States, including Puerto Rico and the American Virgin Islands.

The recall is due to a screw rotation error that occurs when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and the infusion stops.

Healthcare facilities and consumers should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. If a device is affected, users should follow the instructions provided by Hospira Inc. for the recall.

The recalled product

Product
LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.
Manufacturer
Hospira Inc.
Affected units
8,794

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)

  • Serial Number 15553367
  • 16224548
  • 16224939
  • 16225091
  • 16225646
  • 16225851
  • 16226006
  • 16226095
  • 16226117
  • 16226159
  • 16226360
  • 16226383
  • 16226435
  • 16226460
  • 16226680
  • 16226707
  • 16226726
  • 16226730
  • 16226756
  • 16226763

Distribution

Distributed nationwide across the United States.

The notice also names 2 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 →