Company: Hospira, Inc.
Date of Enforcement Report: 12/8/2010
Class ll:
PRODUCT
EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5. Recall # Z-0126-2011
REASON
The EndoTool software did not always provide an audible alert when a blood glucose measurement was due. This could result in a patient not receiving an appropriate dose of insulin.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc., Lake Forest, IL, by letter dated July 23, 2010.
Manufacturer: MD Scientific LLC, Charlotte, NC. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
97 (96/1800.3 and 1/1825.5)
DISTRIBUTION
Nationwide