Agency classClass IIOur severity:High FDA (Devices)·Z-0289-2014·Announced 2013-11-20

Hospira Recalls Plum A+3 Infusion Systems Due to Broken Sensor Pin Risk

Hospira is recalling 21,551 Plum A+3 Infusion Systems because a distal pressure sensor pin may break, potentially preventing the detection of line 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 recall is classified as FDA Class II, and the hazard involves a medical device failure that could prevent the detection of occlusions, posing a risk of harm without reported injuries or fatalities.

Plain-English summary

Hospira Inc. is recalling 21,551 units of the Plum A+3 Infusion System. The recall is due to a potential defect where the distal (occlusion) pressure sensor pin may break. This pin is a critical component of the subsystem that measures pressure within the distal line of the administration set to indicate the presence of a full or partial distal occlusion.

A broken distal pin can only be detected through a visual inspection of the distal pressure pin. If the pin breaks, the system may fail to properly indicate occlusions, which could impact the safe delivery of parenteral, enteral, or epidural infusions.

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 Costa Rica and the Dominican Republic. The recall covers specific serial numbers listed in the official FDA record Z-0289-2014. Healthcare facilities and users should check their inventory against the provided serial number list and contact Hospira for further instructions.

The recalled product

Product: The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural…
Manufacturer: Hospira Inc.
Category: Medical Device — Infusion Pump
Hazard: device-malfunction
occlusion-detection-failure
Affected units: 21,551

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)

1) List Number 20678
Serial Numbers: 15541001
15541011
15541021
15541031
15541041
15541051
15541061
15541071
15541081
15541091
15541101
15541111
15541121
15541131
15541141
15541151
15541161
15541171
15541181

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

Same manufacturer · Hospira Inc.

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Same hazard · device malfunction