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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Category
- Medical Device — Infusion Pump
- 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
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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