The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0283-2014·Announced 2013-11-20

Hospira Recalls Plum A+ Infusers Due to Broken Pressure Sensor Pin

Hospira Inc. is recalling 179 Plum A+ Hyperbaric Infusion Systems because the 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 defect involves a medical device used for infusion therapy where a failure to detect occlusion poses a risk of harm, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Hospira Inc. is recalling 179 units of the Plum A+ Hyperbaric Infusion System. This cassette-based multifunction infusion system is designed to deliver parenteral, enteral, or epidural infusions and is indicated for the administration of whole blood and blood products. The affected units were distributed nationwide in the United States, including Puerto Rico and the U.S. Virgin Islands, as well as in Costa Rica and the Dominican Republic.

The recall is due to a potential defect where the distal (occlusion) pressure sensor pin may break. This pin is part 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 pin can only be detected through visual inspection of the distal pressure pin.

The recall covers specific serial numbers listed in the agency's documentation. Users should check their devices against the provided serial number list and contact Hospira Inc. for further instructions.

The recalled product

Product
The Plum A+ Hyperbaric 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+ Hyperbaric Infusion System is designed to deliver parenteral, enteral…
Manufacturer
Hospira Inc.
Category
Medical Device — Infusion Systems
Hazard
Affected units
179

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 11005
  • Serial Numbers: 16792201
  • 16792202
  • 16792205
  • 16792206
  • 16792208
  • 16792209
  • 16792210
  • 16792211
  • 16792213
  • 16792216
  • 16792217
  • 16792219
  • 16792220
  • 16792222
  • 16792223
  • 16792224
  • 16792225
  • 16792226
  • 16792227

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 →

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