Recall Z-2790-2016— Hospira Inc., A Pfizer Company
Class II · Terminated
Class II FDA medical device recall by Hospira Inc., A Pfizer Company, initiated 2016-07-28, terminated 2018-11-02. It names one FDA 510(k) clearance: K141102. 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.. 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
- Hospira Inc., A Pfizer Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-28
- Terminated
- 2018-11-02
- Firm location
- Lake Forest, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.