Baxter Spectrum IQ Infusion Pump, Product Code 3570009
Reason: One device was improperly performed testing prior to release from a Service Center.
Z-1775-2024May 15, 2024Deerfield, IL
InfuTronix LLC
Class IOngoing
Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
Reason: InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug ...
Z-1285-2024April 3, 2024Natick, MA
InfuTronix LLC
Class IOngoing
Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
Reason: InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug ...
Z-1286-2024April 3, 2024Natick, MA
Zyno Medical LLC
Class IIOngoing
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or o...
Reason: When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a ...
Z-1183-2024March 6, 2024Natick, MA
Smiths Medical ASD Inc.
Class IOngoing
smiths medical Medfusion Model 4000 syringe pump
Reason: Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, ...
Z-0864-2024February 7, 2024Minneapolis, MN
CareFusion 303, Inc.
Class IOngoing
BD Alaris Syringe Module, REF 8110
Reason: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
Z-0185-2024November 15, 2023San Diego, CA
CareFusion 303, Inc.
Class IOngoing
Alaris PCA Module 8120
Reason: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
Z-0186-2024November 15, 2023San Diego, CA
CareFusion 303, Inc.
Class IOngoing
BD Alaris PCU REF 8015
Reason: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
Z-0184-2024November 15, 2023San Diego, CA
Quest Medical, Inc.
Class IIOngoing
Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached need...
Reason: For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity...
Z-0197-2024November 8, 2023Allen, TX
Cardinal Health 200, LLC
Class IOngoing
Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
Reason: Demonstrated recognition and compatibility issues with syringe infusion pumps.
Z-0150-2024November 1, 2023Waukegan, IL
Cardinal Health 200, LLC
Class IOngoing
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Reason: Demonstrated recognition and compatibility issues with syringe infusion pumps.
Z-0145-2024November 1, 2023Waukegan, IL
Cardinal Health 200, LLC
Class IOngoing
Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
Reason: Demonstrated recognition and compatibility issues with syringe infusion pumps.
Z-0147-2024November 1, 2023Waukegan, IL
Cardinal Health 200, LLC
Class IOngoing
Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
Reason: Demonstrated recognition and compatibility issues with syringe infusion pumps.
Z-0149-2024November 1, 2023Waukegan, IL
B. Braun Medical, Inc.
Class IOngoing
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Reason: Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instabi...
Z-0123-2024November 1, 2023Allentown, PA
Cardinal Health 200, LLC
Class IOngoing
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
Reason: Demonstrated recognition and compatibility issues with syringe infusion pumps.
Z-0148-2024November 1, 2023Waukegan, IL
Cardinal Health 200, LLC
Class IOngoing
Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
Reason: Demonstrated recognition and compatibility issues with syringe infusion pumps.
Z-0146-2024November 1, 2023Waukegan, IL
B. Braun Medical, Inc.
Class IOngoing
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Reason: Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instabi...
Reason: Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Z-0094-2024October 25, 2023Netanya, N/A
Smiths Medical ASD Inc.
Class IIOngoing
Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump
Reason: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the forc...
Z-0080-2024October 18, 2023Minneapolis, MN
Smiths Medical ASD Inc.
Class IIOngoing
Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
Reason: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the forc...
Reason: Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
Z-2430-2023August 30, 2023Lake Forest, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT RETRIEVAL PACK, Model...
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Reason: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an i...
Z-2103-2023July 19, 2023Deerfield, IL
Baxter Healthcare Corporation
Class IOngoing
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Reason: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an i...
Z-2104-2023July 19, 2023Deerfield, IL
Iradimed Corporation
Class IIOngoing
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
Reason: Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness ...