Panels › General Hospital › Product code ONB · Class 2
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Regulation 880.5440
1510(k)s in 12 months (41 all time)
3recalls in 12 months (73 all time)
69recalls that name a 510(k)
Top companies in ONB
| Company | 510(k)s | Recalls |
|---|---|---|
| Icu Medical | 4 | 68 |
| Epic Medical Pte. , Ltd. | 12 | 0 |
| Simplivia Healthcare , Ltd. | 6 | 1 |
| Becton, Dickinson and Company | 4 | 0 |
| Equashield Medical , Ltd. | 4 | 0 |
| Becton, Dickinson & CO | 2 | 1 |
| Teva Medical Ltd., Migada Plant | 3 | 0 |
| J & J Solutions, Inc. D/B/A/ Corvida Medical | 2 | 0 |
| B. Braun Medical, Inc. | 0 | 1 |
| BD SWITZERLAND SARL | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2021 | ICU Medical, Inc. REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a cont Open, Classified |
ONB | K173477 |
| Mar 16, 2021 | ICU Medical, Inc. REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s ne Open, Classified |
ONB | K173477 |
| Mar 16, 2021 | ICU Medical, Inc. REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s ne Open, Classified |
ONB | K173477 |
| Mar 16, 2021 | ICU Medical, Inc. REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer - Product Usage: provides access for the administratio Open, Classified |
ONB | K131549 |
| Mar 16, 2021 | ICU Medical, Inc. REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Open, Classified |
ONB | K131549 |
| Mar 16, 2021 | ICU Medical, Inc. REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a c Open, Classified |
ONB | K131549 |
| Mar 16, 2021 | ICU Medical, Inc. REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a c Open, Classified |
ONB | K131549 |
| Mar 16, 2021 | ICU Medical, Inc. REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-In Red Cap - Product Usage: provides access for the administr Open, Classified |
ONB | K131549 |
| Mar 16, 2021 | ICU Medical, Inc. REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container Open, Classified |
ONB | K131549 |
| Aug 31, 2020 | ICU Medical, Inc. 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261; 44 cm(17 IN) Appx 2.9 ml,PUR YELLOW TRANS SET,ChemoClave,CK VLV,Sp Open, Classified |
ONB | None listed |
| Aug 31, 2020 | ICU Medical, Inc. 31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spir Open, Classified |
ONB | None listed |
| Aug 31, 2020 | ICU Medical, Inc. 3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinning Spiros, Red Cap, Open, Classified |
ONB | K173477 |
| Aug 31, 2020 | ICU Medical, Inc. 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, S Open, Classified |
ONB | K131549 |
| Feb 22, 2019 | ICU Medical, Inc. 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 Terminated |
ONB | K131549 |
| Nov 22, 2016 | J&J Solutions, Inc. DBA Corvida Medical Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Cor Terminated |
ONB | K150486 |
| Feb 25, 2016 | ICU Medical, Inc. 31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger, Item No. SL3011 sterile devices intended for the infusion and withdrawal of fluids. Terminated |
ONB | K131549 |
| Feb 25, 2016 | ICU Medical, Inc. 30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. CL3528 sterile devices intended for the infusion and withdrawal of Terminated |
ONB | K131549 |
| Feb 25, 2016 | ICU Medical, Inc. 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 sterile devices intended for the infusion and withdrawal of fluid Terminated |
ONB | K131549 |
| Feb 25, 2016 | ICU Medical, Inc. 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerestories devices intended for the infusion and withdrawal of flu Terminated |
ONB | K131549 |
| Feb 25, 2016 | ICU Medical, Inc. 110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hanger, Item No. AHCL3300 sterile devices intended for the infusion and withdrawal of Terminated |
ONB | K131549 |
| Feb 25, 2016 | ICU Medical, Inc. 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. 011-CL3528 sterile devices intended for the infusion and withdrawal Terminated |
ONB | K131549 |
| Feb 25, 2016 | ICU Medical, Inc. 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Bag Hanger, Item No. 011-CL3511 sterile devices intended for the infusion and withdrawal of fluids. Terminated |
ONB | K131549 |
| Feb 25, 2016 | ICU Medical, Inc. 74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusion and withdrawal of fluids. Drip Chamber, Rotating Luer, Ba Terminated |
ONB | K131549 |
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