Hospira Recalls Plum A+ Infusion Pumps Due to Alarm Failure
Hospira is recalling 190 Plum A+ infusion pumps because their alarm assemblies may fail to sound at any volume level.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class I recall, which mandates a severity score of at least 4 according to the rubric, due to the potential for serious injury or death from alarm failure.
Plain-English summary
Hospira Inc. is recalling 190 units of the Plum A+ Infusion System. The recall involves one lot of alarm assemblies used in these pumps, which may fail to sound at all volume levels.
The affected devices are distributed worldwide, including in the United States, Puerto Rico, and various international locations. The recall is based on the potential for the alarm system to malfunction, which could prevent the device from alerting users to critical infusion status changes.
Healthcare facilities and users should check their serial numbers against the list provided by the FDA to determine if their devices are affected. If a device is included in the recall, users should follow the instructions provided by Hospira for repair or replacement.
The recalled product
- Product
- The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or…
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 190
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)
- 1) List Number:12618: Serial Numbers: 14040926
- 14041563
- 14041565
- 14041611
- 14041627
- 14041901
- 14041912
- 14041921
- 14041953
- 14041960
- 14041964
- 14041973
- 14040654
- 14041065
- 14041554
- 14041604
- 14041606
- 14041621
- 14041902
- 14042270
Distribution
Part of a larger recall action
This product is one of 5 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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