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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira

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 Class 2 Device Recall Hospirasee related information
Date Initiated by FirmJuly 28, 2016
Create DateSeptember 13, 2016
Recall Status1 Terminated 3 on November 02, 2018
Recall NumberZ-2790-2016
Recall Event ID 74903
510(K)NumberK141102 
Product Classification Pump, infusion - Product Code FRN
ProductHospira 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.
Code Information List Numbers 16037-64-02 and 16037-64-03
Recalling Firm/
Manufacturer		 Hospira Inc., A Pfizer Company
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information ContactHospira Global Complaint Management
800-441-4100
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionHospira sent an Urgent Medical Device Correction letter dated July 28, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter provided instructions for step-by-step process to mitigate the issue. Customers with questions were instructed to contact Hospira Global Complaint Management at 1-800-441-4100 or Hospira Technical Service Center at 1-800-241-4002, option 4.
Quantity in Commerce20
DistributionWorldwide Distribution - US including ND, TX, MI, MN, WI, IA, ME, HI, PA, MA, NJ, NY, CT, and Internationally to Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRN
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