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Sources: EU EUDAMED, US FDA
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ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·November 27, 2018
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·November 27, 2018
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·November 27, 2018
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·October 22, 2024
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle catheter (which is inserted into a vein). Directions for Use: icumedical IV Extension Sets Clave/MicroClave/NanoClave Connectors Antimicrobial Clave/MicroClave Connectors Spiros Closed Male Luer.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·July 1, 2020
ICU Medical Plum Solos, Item number 400011001; infusion pump
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·April 22, 2025
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·April 22, 2025
Plum 360/A+ spare batteries. Item Number: SUB0000864.
FDA Recall
Open, Classified
·ICU Medical Inc·Product code FRN·May 7, 2024
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
FDA Recall
Terminated
·ICU Medical Inc·Product code FRN·August 1, 2018
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·December 15, 2025
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·December 15, 2025
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·December 15, 2025
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FJK·August 31, 2020
Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FMF·August 31, 2020
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 units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 13.6 Span, Plum A+3, PLUM A+3 INFUSION PUMPS and Plum A+3 Wireless Refurb, PLUM A+, PLUM A+ Infusion System, PlumA+3IV Pump Multi 1' Set
FDA Recall
Open, Classified
·ICU Medical Inc·Product code FRN·May 7, 2024
30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FPA·August 31, 2020
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusin Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Infusion System, PLUM 360, PLUM 360" Infuser, Plum 360 Infuser compatible with ICU Medical MedNet Software, Plum 360 Infuser compatible with ICU Medical MedNet Software Refurb, Plum 360 sistema infusionale compatibile con ICU Medical MedNet Software, Pompe a perfusion Plum 360, compatible avec le logiciel ICU Medical MedNet
FDA Recall
Open, Classified
·ICU Medical Inc·Product code FRN·May 7, 2024
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code ONB·January 3, 2019
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code ONB·November 6, 2024
Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx 1.5 ml, Bag Spike Adapter w/Spiros, Vented Cap, REF: IB-CH3034C
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FPA·August 31, 2020