Hospira Recalls Plum A+ Infusion Pumps Due to Volume Knob Defect
Hospira is recalling Plum A+ infusion pumps because the volume control knob may reverse the alarm volume direction.
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 hazard involves a functional defect in the volume control knob that may cause alarm volume to increase instead of decrease, representing a moderate risk of user confusion or delayed response to alarms.
Plain-English summary
Hospira Inc. is recalling Plum A+ Single Channel Infusion Pumps equipped with Hospira MedNet Software and a Connectivity Engine peripheral module. The recall covers pumps with list numbers 20679 and 20792, and module list number 20792, across all serial numbers.
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 loud and quiet may be reversed. While the System Operating Manual indicates that clockwise rotation decreases the volume, on affected devices, turning the knob clockwise may increase the alarm volume.
The affected 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+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming…
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pumps
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 (3)
- pump list numbers 20679 and 20792
- and module list number 20677
- 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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