Cl II GemStar infusion pump

Company:Hospira Inc.
Date of Enforcement Report: 7/16/2014
Class lI:

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 fluids, and blood/blood products.
Recall Number Z-2031-2014

REASON
Through customer complaints, Hospira has become aware that in GemStar (Phase 3) infusion pumps, list numbers 13000, 13100, 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 (“code 10/001/000”). This Beeper Error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.

RECALLING FIRM/MANUFACTURER
Hospira Inc., Lake Forest, IL on 1/31/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
36,881 infusion pumps

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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