Hospira LifeCare PCA 3 Pumps Recalled for Screw Rotation Error
Hospira is recalling 69 LifeCare PCA 3 pumps due to a screw rotation error that stops infusion and triggers an alarm.
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 3/5 (High).
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 with a functional defect that stops infusion, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Hospira Inc. is recalling 69 units of the LifeCare PCA 3 pump, identified by PCA Serial List Number 12384. These devices are used for the clinician administration or self-administration of analgesic medications. The recall covers units 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.
The source text does not specify specific consumer actions beyond the recall notice itself, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 69
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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