Home / Recalls / Hospira Inc., A Pfizer Company / Z-2790-2016

Z-2790-2016 Class II Terminated

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

FDA device recall Z-2790-2016 was initiated by Hospira Inc., A Pfizer Company on July 28, 2016 and is designated Class II. 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. The recall status is terminated (terminated November 2, 2018). Affected quantity: 20.

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

Other recalls by Hospira Inc., A Pfizer Company

  • D-0980-2017 Class III — Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, (July 6, 2017)
  • D-0898-2017 Class II — Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only (May 18, 2017)
  • D-0480-2017 Class II — METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Con (February 10, 2017)
  • D-0638-2017 Class I — Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - N (January 24, 2017)
  • Z-1682-2017 Class II — Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of (December 30, 2016)
  • D-0097-2017 Class II — Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Mu (September 16, 2016)
  • D-0096-2017 Class II — Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL (September 16, 2016)
  • D-0218-2017 Class I — Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single- (August 4, 2016)

FDA data resources