Infusion pumps are recalled for distal pressure sensor drift
Hospira recalled 10,669 Plum A+ infusion pumps after reports of distal pressure sensor calibration drift. The issue may cause false occlusion alarms or distal 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 FDA classified this as Class II, but the notice does not report hospitalizations. The rubric rates a risk-of-harm product issue without reported injury as High (3).
Plain-English summary
Hospira Inc. is recalling 10,669 Plum A+ infusion pumps, List No. 11971, identified by the serial numbers in the FDA notice. The pumps are multipurpose infusion systems intended to deliver multiple therapies precisely across general clinical care.
The recall follows reports of distal pressure sensor calibration drift. During setup or infusion, affected pumps may display E180/N180, E181/N181, E186/N186, E187/N187, or E346. A drifted sensor may cause false distal occlusion alarms or distal occlusions.
The notice says users of the pumps may experience these alarms or occlusions. It lists worldwide distribution, including nationwide U.S. distribution, Puerto Rico, the U.S. Virgin Islands, Croatia, the Dominican Republic, and Turks and Caicos. The source does not specify what consumers should do.
The recalled product
- Product
- Plum A+ Infusion Pump; List Number: 11971; 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 care
- 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. 11971
- Serial Numbers: 13120009
- 13120017
- 13120018
- 13120019
- 13120026
- 13120028
- 13120037
- 13120041
- 13120042
- 13120044
- 13120057
- 13120058
- 13120068
- 13120071
- 13120074
- 13120075
- 13120082
- 13120096
- 13120103
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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