Hospira Recalls LifeCare 5000 Infusion Pumps Due to Door Roller Defect
Hospira is recalling LifeCare 5000 infusion pumps because a broken door roller pin may prevent the door from locking the cassette properly, potentially causing alarms or false occlusions.
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 used for critical drug infusion where a mechanical failure could lead to improper administration or alarms, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Hospira Inc. is recalling the LifeCare 5000 Pump (Plum 1.6) infusion pump, which is indicated for the volumetric infusion of critical drugs and fluids by intravenous administration. The recall involves 132,889 units under List Number 02507 with all serial numbers. The products were distributed worldwide, including the United States, Canada, and numerous countries across Europe, Asia, the Middle East, and South America.
The recall is due to a potential defect in the door roller assembly. If the door roller pin breaks, the door may not be able to appropriately lock the cassette in the right position. Depending on the specific conditions of the break, this may result in the door not closing, a cassette or door alarm, or a false occlusion.
Healthcare providers and consumers should stop using the affected pumps and contact Hospira Inc. for further instructions on replacement or repair.
The recalled product
- Product
- LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
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 (2)
- List Number: 02507
- Serial Numbers: All.
Distribution
Part of a larger recall action
This product is one of 3 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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