Hospira Plum A+ Infusion Pumps Recalled for Reversed Volume Control Knob
Hospira is recalling Plum A+ Hyperbaric Infusion Pumps because the volume control knob may function in reverse, causing alarm volume to increase when turned clockwise.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The defect involves a reversed volume control knob, which is a functional issue that does not pose a direct risk of serious injury or death, fitting the criteria for a low-severity recall.
Plain-English summary
Hospira Inc. is recalling Plum A+ Hyperbaric Single Channel Infusion Pumps equipped with Hospira MedNet Software and a Connectivity Engine peripheral module. The recall is due to a defect in the volume control knob located on the back of the infuser. On some devices, the direction for increasing and decreasing the alarm volume is reversed compared to the System Operating Manual.
The manual indicates that a clockwise rotation of the knob decreases the volume; however, on the affected devices, the alarm volume increases when the knob is turned clockwise. This discrepancy may cause users to inadvertently increase the alarm volume instead of decreasing it.
The affected products include pumps with list number 11005 and modules with list number 11006, covering all serial numbers. The products were distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international locations. Users should contact Hospira for further instructions regarding the recall.
The recalled product
- Product
- Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the…
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
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)
- pump list number 11005 and module list number 11006
- all serial numbers
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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