Hospira Recalls Plum A+ Hyperbaric Infusion Pumps Due to Door Roller Defect
Hospira is recalling 180 Plum A+ Hyperbaric Infusion Pumps because a door roller assembly may break, potentially causing unrestricted flow or over-delivery of medication.
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 mechanical defect that could lead to over-delivery of medication, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Hospira, Inc. is recalling 180 units of the Plum A+ Hyperbaric Single Channel Infusion Pumps. The recall affects list number 11005 and all serial numbers. These devices are exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
The recall was initiated because the door roller assembly on the Plum A+/A+3 infuser family has the potential to break. If this occurs, it can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.
The affected products were distributed worldwide, including the United States (including Puerto Rico) and numerous international locations such as Austria, Australia, Argentina, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates, and Vietnam. Users should contact Hospira for further instructions on how to address this defect.
The recalled product
- Product
- Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 180
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)
- list number 11005
- all serial numbers
Distribution
Distributed in 1 state:
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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