Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Model ...
Reason: Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be...
Z-1996-2021July 7, 2021Mansfield, MA
The Biomed Guys
Class IOngoing
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
Reason: Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. ...
Z-1651-2021June 9, 2021Clarksville, TN
STEP-HAR MEDICAL LLC
Class ITerminated
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Reason: Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel....
Z-1543-2021May 19, 2021Fountain Valley, CA
Infusion Pump Repair
Class IOngoing
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Reason: Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel....
Z-1544-2021May 19, 2021Irvine, CA
Baxter Healthcare Corporation
Class IITerminated
Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
Reason: Potentially defective component in the AC power adapter which may fail over time.
Z-1487-2021May 5, 2021Medina, NY
Pacific Medical Group Inc.
Class IOngoing
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
Reason: Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel com...
Reason: Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel....
Z-1332-2021April 14, 2021Santa Ana, CA
Tenacore LLC
Class ITerminated
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
Reason: Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel....
Z-1331-2021April 14, 2021Santa Ana, CA
Cardinal Health 200, LLC
Class IICompleted
Enteral Infusion Pump
Reason: The potential for air appearing in the enteral feed pumping set tubing during set-up.
Z-1347-2021April 14, 2021Waukegan, IL
CareFusion 303, Inc.
Class IOngoing
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
Reason: Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may ...
Z-1309-2021April 7, 2021San Diego, CA
Baxter Healthcare Corporation
Class IITerminated
Infusion Pump
Reason: Battery performance issues related to prolonged storage.
Z-1150-2021March 3, 2021Medina, NY
Alung Technologies Inc
Class IITerminated
ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr conti...
Reason: CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy
Z-0938-2021February 10, 2021Pittsburgh, PA
Baxter Healthcare Corporation
Class IIOngoing
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
Reason: There is a potential software error during programming.
Z-0714-2021December 30, 2020Deerfield, IL
Baxter Healthcare Corporation
Class IIOngoing
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Reason: There is a potential software error during programming.
Z-0712-2021December 30, 2020Deerfield, IL
Baxter Healthcare Corporation
Class IIOngoing
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Reason: There is a potential software error during programming.
Z-0713-2021December 30, 2020Deerfield, IL
CME America LLC
Class IITerminated
CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: ...
Reason: The wall charger may not properly charge the infusion pump battery.
Z-0305-2021November 4, 2020Golden, CO
Baxter Healthcare Corporation
Class ITerminated
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Reason: Baxter is updating the device IFU for safety communication regarding cleaning practices.
Z-0122-2021October 28, 2020Deerfield, IL
Baxter Healthcare Corporation
Class ITerminated
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
Reason: Baxter is updating the device IFU for safety communication regarding cleaning practices.
Z-0120-2021October 28, 2020Deerfield, IL
Baxter Healthcare Corporation
Class ITerminated
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Reason: Baxter is updating the device IFU for safety communication regarding cleaning practices.
Z-0121-2021October 28, 2020Deerfield, IL
CareFusion 303, Inc.
Class IOngoing
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
Reason: Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusio...
Z-2939-2020September 16, 2020San Diego, CA
CareFusion 303, Inc.
Class IIOngoing
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate...
Reason: Infusion pump component defect may result in interruption of patient monitoring
Z-2935-2020September 9, 2020San Diego, CA
Smiths Medical ASD Inc.
Class IOngoing
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
Reason: Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Z-2735-2020August 12, 2020Minneapolis, MN
CareFusion 303, Inc.
Class ITerminated
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Reason: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infus...
Z-2721-2020August 12, 2020San Diego, CA
CareFusion 303, Inc.
Class ITerminated
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
Reason: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infus...
Z-2717-2020August 12, 2020San Diego, CA
CareFusion 303, Inc.
Class ITerminated
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Reason: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infus...