The Recall Desk
HighFDA (Devices)·Z-2722-2016·Announced 2016-09-14

Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

Hospira Inc. is recalling 357,778 Plum A+ Hyperbaric Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruptions.

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 involves a risk of harm (delay or interruption of therapy) without reported injuries or fatalities, meeting the criteria for a High severity score.

Plain-English summary

Hospira Inc. is recalling 357,778 units of the Plum A+ Hyperbaric Infusion Pump, List Number 11005. The recall covers devices distributed nationwide in the United States, including Puerto Rico and the U.S. Virgin Islands, as well as in Costa Rica, Turks and Caicos, and the Dominican Republic.

The recall was initiated because the fluid shield diaphragm for these infusion pumps was undersized. This defect may result in alarms or the delay or interruption of therapy. The agency has classified this as a Class II recall.

Healthcare facilities and users should check their inventory for the specific serial numbers listed in the official recall notice. Affected units should be removed from service and returned to Hospira Inc. for evaluation or replacement.

The recalled product

Product
Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, micro
Manufacturer
Hospira Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
357,778

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 Number 11005. Serial numbers: 16792201
  • 16792202
  • 16792205
  • 16792206
  • 16792208
  • 16792209
  • 16792210
  • 16792211
  • 16792213
  • 16792216
  • 16792217
  • 16792219
  • 16792220
  • 16792222
  • 16792223
  • 16792224
  • 16792225
  • 16792226
  • 16792227
  • 16792228

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

Related recalls

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Same hazard · device malfunction

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