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Health product recall

Gemstar Pumps (2014-02-04)

Starting date:
February 4, 2014
Posting date:
March 25, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-38551

Recalled Products

Gemstar Pumps

Reason

In Gemstar (Phase 3) infusion pumps, list numbers 13000 and 13150, the connection between the beeper subassembly and the pump may fail. The Gemstar infusion pump will identify this failure during the "self-test" while powering up which will result in a beeper error (X100). This beeper error (X100) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.

Affected products

Gemstar Pumps

Lot or serial number

13000-XX-YY
13150-XX-YY

Model or catalog number

All serial numbers 

Companies
Manufacturer
Hospira Inc.
275 North Field Drive
Lake Forest
60045
Illinois
UNITED STATES