Z-2790-2016 Class II Terminated

Recalled by Hospira Inc., A Pfizer Company — Lake Forest, IL

Recall Details

Product Type
Devices
Report Date
September 21, 2016
Initiation Date
July 28, 2016
Termination Date
November 2, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - US including ND, TX, MI, MN, WI, IA, ME, HI, PA, MA, NJ, NY, CT, and Internationally to Canada.

Code Information

List Numbers 16037-64-02 and 16037-64-03