The Recall Desk
ModerateFDA (Devices)·Z-2031-2014·Announced 2014-07-16

Hospira Recalls GemStar Infusion Pumps Due to Beeper Connection Failure

Hospira is recalling 36,881 GemStar infusion pumps because the beeper subassembly connection may fail, rendering the device inoperable.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classifies this as a Class II recall. The hazard results in the pump becoming inoperable during self-test, which is a functional defect that prevents use but does not involve reported injuries or immediate life-threatening hazards.

Plain-English summary

Hospira Inc. is recalling 36,881 GemStar infusion pumps, including List numbers 13000, 13100, and 13150. These devices are used for intravenous, arterial, subcutaneous, short-term epidural infusion, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood products.

The recall is due to a potential failure in the connection between the beeper subassembly and the pump. If this connection fails, the pump identifies the issue during its power-up self-test and displays a Beeper Error (code 10/001/000). This error is a service alarm that places the pump in an inoperable mode, requiring service before it can be returned to use.

The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. Users should check their pump serial numbers against the recall list and contact Hospira for service if the device is affected.

The recalled product

Product
GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluid
Manufacturer
Hospira Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
36,881

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: 13000
  • Serial Numbers: 9221423
  • 12470045
  • 12470063
  • 12470085
  • 12470109
  • 12470130
  • 12470133
  • 12470135
  • 12470138
  • 12470144
  • 12470145
  • 12470147
  • 12470152
  • 12470153
  • 12470154
  • 12470156
  • 12470157
  • 12470158
  • 12470160

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

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