Hospira Recalls Infusion Pumps Due to Door Roller Assembly Breakage Risk
Hospira is recalling specific Plum XL and LifeCare infusion pumps because a door roller assembly may break, preventing the cassette door from locking properly.
What this means for you
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 high-risk medical device (infusion pump) with a mechanical defect that could lead to improper medication administration or alarms, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Hospira Inc. is recalling the Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. These are infusion pumps used for intravenous, arterial, short-term epidural, and parenteral administration of fluids, medications, and blood products in hospital and home care environments.
The recall is due to a potential defect where the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers may break. If the door roller pin breaks, the door cannot 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 identified by List Numbers 11781, 11845, and 11846, with all serial numbers affected. The products were distributed worldwide, including the United States, Canada, and numerous countries in Europe, Asia, South America, and the Middle East. Users should contact Hospira for further instructions on how to address the defect.
The recalled product
- Product
- Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, an
- 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: 11781
- Serial Numbers: All. List Number: 11845
- Serial Numbers: All. List Number: 11846
- 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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