Company: Hospira Inc.
Date of Enforcement Report 9/21/2016
Class lI:
PRODUCT
Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps..
Recall Number Z-2790-2016
REASON
Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units..
RECALLING FIRM/MANUFACTURER
Hospira Inc., Lake Forest, IL on 9/13/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
20
DISTRIBUTION
Nationwide and Canada
___________________________________
