Hospira LifeCare PCA Infusion System Recalled for Door Design Flaw
Hospira is recalling 38,882 LifeCare PCA infusion systems because the clear plastic door design allows excessive flexing, permitting unauthorized access to medication vials.
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 is classified as FDA Class II. The hazard involves unauthorized access to medication, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Hospira Inc. is recalling 38,882 units of the LifeCare PCA infusion system with Hospira MedNet software. The recall is due to a design defect in the clear plastic door of the infusion pump, which allows for excessive flexing. This design flaw permits unauthorized access to the vial of medication.
The affected devices were distributed worldwide, including all 50 US states, the District of Columbia, Puerto Rico, the American Virgin Islands, and Canada. The recall covers specific serial numbers listed in the official FDA record Z-1518-2015.
Clinicians and patients using these systems for the administration of analgesia within programmed limits should contact Hospira Inc. for instructions on how to proceed. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits.
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 38,882
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: 20709
- Serial Numbers: 15551001
- 15551002
- 15551003
- 15551004
- 15551005
- 15551007
- 15551009
- 15551010
- 15551011
- 15551012
- 15551013
- 15551014
- 15551015
- 15551016
- 15551017
- 15551018
- 15551019
- 15551020
- 15551021
Distribution
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.
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