Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Reason: The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or...
Z-3153-2024October 2, 2024North Andover, MA
CareFusion 303, Inc.
Class IIOngoing
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Reason: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Z-3138-2024September 25, 2024San Diego, CA
CareFusion 303, Inc.
Class IIOngoing
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Reason: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Z-3139-2024September 25, 2024San Diego, CA
CareFusion 303, Inc.
Class IIOngoing
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Reason: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Z-3142-2024September 25, 2024San Diego, CA
CareFusion 303, Inc.
Class IIOngoing
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Reason: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Z-3140-2024September 25, 2024San Diego, CA
CareFusion 303, Inc.
Class IIOngoing
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Reason: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Z-3141-2024September 25, 2024San Diego, CA
Baxter Healthcare Corporation
Class IIOngoing
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
Reason: The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers whe...
Z-2582-2024August 28, 2024Deerfield, IL
Baxter Healthcare Corporation
Class IIOngoing
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spec...
Reason: The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers whe...
Z-2581-2024August 28, 2024Deerfield, IL
ICU Medical Inc
Class IOngoing
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS ...
Reason: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery run...
Z-2448-2024August 21, 2024Lake Forest, IL
Smiths Medical ASD Inc.
Class IOngoing
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into...
Reason: CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode A...
Z-2419-2024August 14, 2024Minneapolis, MN
Smiths Medical ASD Inc.
Class IOngoing
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves...
Reason: The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidur...
Z-2421-2024August 14, 2024Minneapolis, MN
Smiths Medical ASD Inc.
Class IOngoing
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epid...
Reason: The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidur...
Reason: Improperly performed testing prior to release
Z-2530-2024August 14, 2024Deerfield, IL
B Braun Medical Inc
Class IIOngoing
Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 ea...
Reason: Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syrin...
Z-2437-2024July 31, 2024Breinigsville, PA
B Braun Medical Inc
Class IIOngoing
Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product Description: Perfusor Space Syringe Pump, Infusion ...
Reason: Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syrin...
Z-2434-2024July 31, 2024Breinigsville, PA
B Braun Medical Inc
Class IIOngoing
Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Compone...
Reason: Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syrin...
Z-2433-2024July 31, 2024Breinigsville, PA
B Braun Medical Inc
Class IIOngoing
Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each Component: N/A
Reason: Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syrin...
Z-2436-2024July 31, 2024Breinigsville, PA
B Braun Medical Inc
Class IIOngoing
Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, Infusion Pump, 1 each Component: N/A
Reason: Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syrin...
Z-2435-2024July 31, 2024Breinigsville, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362034
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2380-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 490102
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2399-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354213
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2377-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 480263
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2396-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363430
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2392-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362431
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2383-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 362033
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...