Tag

infusionpump
Company:Smiths Medical ASD Inc..Date of Enforcement Report 3/28/2018 Class lI: PRODUCT The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal,...
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Company:ICU Medical IncDate of Enforcement Report 12/13/2017 Class lI: PRODUCT ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers:(a) 16037-64-01; MedNet 6.1b) 16037-64-02; MedNet 6.1c) 16037-64-03; MedNet 6.1d) 16037-64-04; MedNet 6.21The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible infusion...
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Company:ICU Medical IncDate of Enforcement Report 11/22/2017 Class lI: PRODUCT Plum 360 Infusion System, List number 30010. Recall Number Z-0101-2018 REASON (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the “Paused” state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be...
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Company:Beckman Coulter Inc.. Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012....
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Company: Hospira, Inc. Date of Enforcement Report 4/5/2017 Class lI: PRODUCT Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions Recall Number Z-1682-2017 REASON Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy...
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Company: Medtronic Neuromodulation Date of Enforcement Report 4/5/2017 Class lI: PRODUCT SynchroMed II implantable drug infusion pump, Model 8637-40, Recall Number Z-1694-2017 REASON Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from...
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Company: CareFusion 303, Inc. Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System. Recall Number Z-1520-2017 REASON Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered...
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Company: Smiths Medical ASD, Inc. Date of Enforcement Report 3/22/2017 Class lI: PRODUCT CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15, Recall Number Z-1439-2017 REASON I20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key...
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Company:Medtronic Neuromodulation Date of Enforcement Report 3/8/2017 Class l PRODUCT Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N’Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Recall Number Z-0788-2017 REASON Medtronic is following...
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http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm398226.htm
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Company: Carefusion Date of Enforcement Report 1/25/2017 Class I: PRODUCT Product Description: Alaris Syringe Pump Module (Large Volume Pump), Model No. 8100 and AIL sensor kits Recall number Z-0950-2017 REASON CareFusion is recalling the Alaris Syringe Pump because of a faulty Air-In-Line (AIL) sensor which may generate a false alarm, and cause the syringe pump...
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Company: Medtronic Neuromodulation Date of Enforcement Report 12/28/2016 Class lI: PRODUCT Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N’Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The SynchroMed II Programmable...
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Zyno Medical LLCProduct: infusion pumps Date:12/5/2016 Failure to establish and maintain procedures to control product that does not conform to specified requirements, and to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a). For example: Your firm did not open a non-conforming report (NCR) on 7/30/15, when...
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Company:Hospira Inc.. Date of Enforcement Report 11/9/2016 Class lI: PRODUCT Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026 Recall Number Z-0353-2017 REASON Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of...
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Company:Hospira Inc.. Date of Enforcement Report 11/9/2016 Class lI: PRODUCT Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027 Recall Number Z-0354-2017 REASON Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of...
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Company: Hospira, Inc. Date of Enforcement Report 11/3/2016 Class lI: PRODUCT Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous,...
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Company: Hospira, Inc. Date of Enforcement Report 11/3/2016 Class lI: PRODUCT Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous,...
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Company:Invivo Corporation Date of Enforcement Report 9/28/2016 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 Frozen...
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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...
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Company: WalkMed Infusion LLC Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000)The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution. Recall Number Z-2219-2016 REASON WalkMed Infusion, LLC Announces a...
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Company: CareFusion 303 Inc..Date of Enforcement Report 3/30/2016 Class lI: PRODUCT Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092. Recall Number Z-1239-2016 REASON CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a “System Error” or “Missing Battery” error code (120.4630). RECALLING FIRM/MANUFACTURER CareFusion...
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Company:.WalkMed Infusion, LLC.Date of Enforcement Report 12/16/2015 Class lI: PRODUCT WalkMed Infusion Triton Infusion Pump (model 300000). Packaged in a single pump box. Four pump boxes are place in an over-shipper for distribution. Recall Number Z-0369-2016 REASON WalkMed Infusion is conducting a field action on the Triton Infusion Pumps (model numbers 300000 and 400000) because...
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Company: CareFusion 303, Inc. Date of Enforcement Report 7/2/2015 Class l: PRODUCT A syringe pump is a small infusion pump that delivers fluids, such as nutrients and medications, into a patient?s body in controlled amounts. They are widely used in clinical settings such as hospitals, nursing homes, and in the home.. REASON An error in...
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Company: CareFusion 303, Inc. Date of Enforcement Report 6/24/2015 Class lI: PRODUCT Alaris PC unit model 8015, software version 9.17 Infusion Pump. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit. Recall Number Z-1811-2015 REASON CareFusion...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a...
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FDA issued a Medwatch alert for infusion pumps May 13, 2015, regarding security vulnerabilities in Hospira’s LifeCare PCA3 and PCA5 Infusion Pump Systems.  A researcher has shown that exploiting the vulnerabilities could allow an unauthorized user to remotely modify the dosage delivered.  Homeland security was previously working with Hospira about this vulnerability (we reported on...
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Hospira Lifecare PCA infusion pump running “SW ver 412” does not require authentication for Telnet sessions, which allows remote attackers to gain root privileges via TCP port 23.  The U.S. Department of Homeland Security has been working with Hospira to get this resolved and Hospira will be performing a recall to correct this.
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Company:Baxter Healthcare CorpDate of Enforcement Report: 4/22/2015 Class lI: PRODUCT Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids. Recall...
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Company:CareFusion 303, Inc.Date of Enforcement Report: 4/1/2015 Class lI: PRODUCT Alaris PC units, Model No. 8015. Infusion pump. Recall Number Z-1311-2015 REASON CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the “Power-On Self Test” due to a keypad issue. RECALLING FIRM/MANUFACTURER CareFusion...
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Company:Hospira Inc..Date of Enforcement Report: 5/28/2014 Class l: PRODUCT Plum A+ infusion pumps and Plum A+3 infusion pumps REASON he Plum A+ and A+3 infusion pumps have an alarm that should sound when a therapy is interrupted. Some of the alarms may fail to sound in situations that should trigger it. It is possible for...
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Company:CME America, LLC.Date of Enforcement Report: 2/25/2015 Class lI: PRODUCT BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP Recall Number Z-1126-2015 REASON CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery. RECALLING FIRM/MANUFACTURER CME America, LLC, Golden, CO on 1/16/2015 Voluntary: Firm...
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Company: Annimas Corp. Date of Enforcement Report 2/11/2015 Class lI: PRODUCT Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. Recall Number Z-1034-2015 REASON ICalibration factors in the pump overwritten during a programming step. The force sensor...
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/docs/FDAinfusionpumplifecycleguidance-ucm209337.pdf
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Company: Smiths Medical ASD, Inc. Date of Enforcement Report 11/12/2014 Class lI: PRODUCT CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump,...
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Company: Baxter Healthcare Corp..Date of Enforcement Report:10/7/2014 Class lI: PRODUCT SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids. Recall Number Z-2738-2014 REASON One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014....
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Company:Hospira Inc.Date of Enforcement Report: 7/30/2014 Class lI: PRODUCT The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today’s evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or...
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Company:Hospira Inc.Date of Enforcement Report: 7/16/2014 Class lI: PRODUCT GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. Recall Number Z-2031-2014 REASON Through customer complaints, Hospira has...
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Company: Codman & Shurtleff, Inc Date of Enforcement Report:5/21/2014 Class lI: PRODUCT MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Recall Number Z-1571-2014 REASON A...
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Company: CareFusion 303, Inc.Date of Enforcement Report:4/23/2014 Class I: PRODUCT Alaris Pump Module (Model 8100), Software Version 9.1.18 The Alaris Pump Model 8100 is a large volume infusion pump. It is intended for use in health care facilities that use infusion for the delivery of fluids, medicines, blood, and blood products using continuous or periodic...
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Company: Hospira Inc..Date of Enforcement Report:5/7/2014 Class I: PRODUCT GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX Recall Number Z-1512-2014 REASON There...
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Company: Baxter Healthcare CorporationDate of Enforcement Report:2/7/2014 Class I: PRODUCT Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB Affected products were manufactured from July 1, 2005 through January 15, 2014 and distributed from February 20, 2013 through January 15, 2014. Use: Sigma Spectrum Infusion Pumps with Master Drug Library are...
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Company: B. Braun Medical, Inc.Date of Enforcement Report:2/122014 Class lI: PRODUCT B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications. Recall Number Z-0921-2014 REASON Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion...
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Company: Hospira Inc Date of Enforcement Report: 11/25/2013 Class l: PRODUCT Hospira GemStar Infusion System Models 13000, 13100, 13150, 13086, 13087, 13088 The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. The device is intended for use in intravenous, arterial, subcutaneous,...
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Company: Hospira Inc Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT ) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with...
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Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit Company: Iradimed Corporation Date of Enforcement Report: 8/12/13 Date Recall Initiated: 7/1/2013 Class l: PRODUCT MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium...
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Company:Symbios Medical Products.Date of Enforcement Report 6/12/2013 Class I: PRODUCT Part 510031 Disposable Single Infusion Pump, quantity Includes… TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO… found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 510042 – BP, w/ Epidural...
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Company:Carefusion Corp..Date of Enforcement Report 4/24/2013 Class Il: PRODUCT Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. Recall Number Z-1112-2013 REASON The recall was initiated because Carefusion has identified potential risk associated with bolus programming...
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Company:Zyno Medical LLC .Date of Enforcement Report 4/10/2013 Class ll: PRODUCT Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient. Recall Number Z-1024-2013 REASON Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the...
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Company:Animas Corporation Date of Enforcement Report 4/10/2013 Class l: PRODUCT Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. Recall Number Z-0993-2013 REASON Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component...
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Company:Hospira Inc. Date of Enforcement Report 10/26/12 Class l: PRODUCT Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes,...
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FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
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