Agency classClass IIOur severity:High FDA (Devices)·Z-0204-2014·Announced 2013-11-20

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.

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 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
Hazard: device-malfunction
occlusion

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

Distributed nationwide across the United States.

The notice also names 51 states specifically:

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.

See all 7 products in this recall →

Same manufacturer · Hospira Inc.

See all →

Critical
Hospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
Moderate
Hospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
Low
Hospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
Severe
Hospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
High
Hospira Symbiq Infusion Pump Recalled for White Screen Shutdown
FDA (Devices) · 2016-11-16

Same hazard · device malfunction