Hospira Recalls Plum A+ Hyperbaric Infusion Pumps Due to Calibration Drift
Hospira is recalling 179 Plum A+ Hyperbaric Infusion Pumps because distal pressure sensor calibration drift may cause false alarms or occlusions.
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 is classified as FDA Class II, and the hazard involves a medical device malfunction (calibration drift) that could lead to false alarms or occlusions, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Hospira Inc. is recalling 179 units of the Plum A+ Hyperbaric Infusion Pump (List Number 11005). The recall is due to reports of distal pressure sensor calibration drift on these devices.
The affected pumps may display specific error codes during setup or infusion, including E180/N180, E181/N181, E186/N186, E187/N187, or E346, which signify possible calibration drift. If the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be genuine.
The affected units were distributed nationwide in the United States, including all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, as well as in Croatia, the Dominican Republic, and Turks and Caicos. Users should identify their devices by checking the serial numbers listed in the official recall notice and contact Hospira for further instructions.
The recalled product
- Product
- Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical car
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
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)
- List No. 11005
- Serial Numbers: 16792201
- 16792202
- 16792205
- 16792206
- 16792208
- 16792209
- 16792210
- 16792211
- 16792213
- 16792216
- 16792217
- 16792219
- 16792220
- 16792222
- 16792223
- 16792224
- 16792225
- 16792226
- 16792227
Distribution
Part of a larger recall action
This product is one of 7 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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