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
