May

2011

Cl ll GemStar SP Infusion Suite Database

Company: Hospira Inc.
Date of Enforcement Report 5/4/2011
Class ll:

PRODUCT
GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; list 13092-04-01. A stand-alone PC application for administration of medications specific to the GemStar Infuser. Recall # Z-1999-2011

REASON
The software enables programming of the GemStar device for a Bolus Lower Lockout Limit outside of the hard limits entered into the GemStar SP Infusion Suite Database PC application.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, letters dated March 23, 2011.
Manufacturer: Hospira Inc., Morgan Hill, CA. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
139 units

DISTRIBUTION
Nationwide, Canada, Chile, Colombia and Singapore

About the author

Amy Sellers

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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Cl ll GemStar SP Infusion Suite Database

Amy Sellers

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