Hospira Infusion Pumps Recalled for Door Roller Assembly Defect
Hospira is recalling specific Plum XL and Micro Macro infusion pumps because a door roller assembly may break, preventing the cassette from locking properly.
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 improper administration of fluids or medications. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Hospira Inc. is recalling specific models of Plum XL, Micro Macro Plum XL3, and Micro Macro Plum XL infusion pumps. These devices are indicated for the intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.
The recall is due to a potential defect in the door roller assembly. If the door roller pin breaks, the door may not be able to appropriately lock the cassette in the right position. This malfunction can result in the door not closing, a cassette or door alarm, or a false occlusion alarm.
The affected units are distributed worldwide, including the United States, Puerto Rico, US Virgin Islands, and numerous international locations. The recall covers List Numbers 11555, 11855, and 11859, with all serial numbers affected. Users should contact Hospira for further instructions on how to address the defect.
The recalled product
- Product
- Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to…
- 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 (4)
- List Number: 11555
- Serial Numbers: All. List Number: 11855
- Serial Numbers: All. List Number: 11859
- Serial Numbers: All.
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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