Hospira Recalls LifeCare PCA Infusion Systems Due to Occlusion Detection Failure
Hospira is recalling 38,878 LifeCare PCA infusion systems because wear on a component may prevent the pump from detecting distal occlusions, a defect that has resulted in one serious injury.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and the source text explicitly states that one instance of the defect resulted in a serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Hospira Inc. is recalling 38,878 LifeCare PCA infusion systems equipped with Hospira MedNet software. These devices are used in various clinical settings, including medical, surgical, and critical care units, to allow clinicians or patients to administer analgesia within programmed limits.
The recall is due to reports that the pumps may fail to detect distal occlusions. This issue is caused by normal wear and tear on the Half Nut, a component that travels up and down the lead screw. When worn, the Half Nut may not properly detect the pressure build-up associated with a distal occlusion. Hospira has received reports of this failure, one of which resulted in a serious injury.
The affected units were distributed nationwide to all 50 states, the District of Columbia, Puerto Rico, and the Virgin Islands, as well as foreign markets. Specific serial numbers are listed in the recall documentation. Users should check their device serial numbers against the provided list and contact Hospira for instructions on how to proceed.
The recalled product
- Product
- LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 38,878
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 No. 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 4 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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