Panels › General Hospital › Product code FRN · Class 2
Pump, Infusion
Regulation 880.5725
2510(k)s in 12 months (849 all time)
24recalls in 12 months (724 all time)
672recalls that name a 510(k)
Top companies in FRN
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp | 51 | 128 |
| Hospira, Inc. | 12 | 129 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 78 |
| Abbott Laboratories | 67 | 4 |
| Carefusion 303, Inc. | 4 | 61 |
| Icu Medical, Inc. | 4 | 43 |
| Smiths Medical Asd, Inc. | 1 | 42 |
| B.Braun Medical, Inc. | 11 | 22 |
| Y | 26 | 0 |
| Zevex International, Inc. | 0 | 25 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, Terminated |
FRN | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, Terminated |
FRN | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUMSET 15 Micron Filter in Sight Chamber, CLAVE Port, 0.2 Micron Filter, CLAVE Y-Si Terminated |
FRN | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 1 Terminated |
FRN | K171346 |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit pe Terminated |
FRN | K171346 |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inc Terminated |
FRN | K171346 |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 uni Terminated |
FRN | K171346 |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per Terminated |
FRN | K171346 |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouch Terminated |
FRN | K171346 |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure L Terminated |
FRN | K141789 |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene- Terminated |
FRN | K982159 |
| Jul 23, 2019 | InfuTronix LLC Nimbus Administration Set, REF HS-004, UDI # 00817170020031
Product Usage:
Administer fluids/medication from a container to a patient through a needle or a catheter. Terminated |
FRN | K140792 K153193 |
| Jul 23, 2019 | Zevex Incorporated (dba MOOG Medical Devices Group) MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm nam Terminated |
FRN | K981816 |
| Jul 23, 2019 | Zevex Incorporated (dba MOOG Medical Devices Group) MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile.
Product Usage:
Administration set to Terminated |
FRN | K981816 |
| Jul 16, 2019 | CareFusion 303, Inc. Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin.
The following products are affected by this recall as they are pumps or pump assemblies with bezels m Terminated |
FRN | K133532 |
| Jun 21, 2018 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used Terminated |
FRN | K133801 |
| May 8, 2018 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2
Product Usage:
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be us Terminated |
FRN | K133801 |
| May 8, 2018 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB
Product Usage:
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is inten Terminated |
FRN | K042121 |
| May 4, 2018 | Baxter Healthcare Corporation Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE
Product Usage:
The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the cont Terminated |
FRN | K042121 |
| May 4, 2018 | Baxter Healthcare Corporation Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP
Product Usage:
The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the cont Terminated |
FRN | K042121 |
| May 4, 2018 | Baxter Healthcare Corporation Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR
Product Usage:
The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the contr Terminated |
FRN | K042121 |
| May 4, 2018 | Baxter Healthcare Corporation Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL
Product Usage:
The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the contr Terminated |
FRN | K042121 |
| May 4, 2018 | Baxter Healthcare Corporation Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX
Product Usage:
The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the contro Terminated |
FRN | K042121 |
| Apr 13, 2018 | Smiths Medical ASD Inc. Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism Terminated |
FRN | K040899 K111386 |
| Mar 5, 2018 | Smiths Medical ASD Inc. Medfusion Syringe Pump 3010 Series
The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood Terminated |
FRN | K040899 |
| Mar 5, 2018 | Smiths Medical ASD Inc. Medfusion Syringe Pump 3500 Series
The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood Terminated |
FRN | K040899 |
| Mar 5, 2018 | Smiths Medical ASD Inc. Medfusion Syringe Pump 4000 Series
The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood Terminated |
FRN | K111386 |
| Jan 5, 2018 | Repro-Med Systems, Inc. Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180. Terminated |
FRN | K933652 |
| Jan 2, 2018 | Smiths Medical ASD Inc. CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY Terminated |
FRN | K982838 |
| Dec 2, 2017 | Fresenius Vial Sa Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthca Terminated |
FRN | K121613 |
| Nov 17, 2017 | CareFusion 303, Inc. Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion.
The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and Terminated |
FRN | K023264 |
| Oct 30, 2017 | ICU Medical Inc ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers:
(a) 16037-64-01; MedNet 6.1
b) 16037-64-02; MedNet 6.1
c) 16037-64-03; MedNet 6.1
d) 16037-64-04; MedNet 6.21
The Terminated |
FRN | K141102 |
| Oct 30, 2017 | ICU Medical Inc Plum 360 Infusion System, List number 30010. Terminated |
FRN | K161469 |
| Oct 6, 2017 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB.
Intended to be used for the controlled administration of fluids. Terminated |
FRN | K133801 |
| Sep 27, 2017 | WalkMed, LLC Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Part Number 204821 Catalog Number IPR-150/10 150 mL
The WalkMed R Terminated |
FRN | K870524 |
| Sep 25, 2017 | Smiths Medical ASD Inc. CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD- Terminated |
FRN | K843772 |
| Sep 25, 2017 | Smiths Medical ASD Inc. CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).REF 21- Terminated |
FRN | K843772 |
| Sep 25, 2017 | Smiths Medical ASD Inc. CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7 Terminated |
FRN | K843772 |
| Aug 22, 2017 | Smiths Medical ASD Inc. Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK.
In the administration of Terminated |
FRN | K040899 |
| Aug 22, 2017 | Smiths Medical ASD Inc. Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK.
In the administration of f Terminated |
FRN | K111386 |
| Aug 9, 2017 | CareFusion 303, Inc. Alaris Pump Module model 8100 manufactured between November 2011 and March 2012;
Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012;
Al Open, Classified |
FRN | K950419 |
| Jul 7, 2017 | ICU The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a Terminated |
FRN | K070398 |
| Jul 7, 2017 | ICU The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a Terminated |
FRN | K070398 |
| Jul 7, 2017 | ICU The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a Terminated |
FRN | K070398 |
| Jul 7, 2017 | ICU The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a Terminated |
FRN | K070398 |
| Jul 7, 2017 | ICU The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a Terminated |
FRN | K070398 |
| Jul 7, 2017 | ICU The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a Terminated |
FRN | K070398 |
| Jul 7, 2017 | ICU The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a Terminated |
FRN | K070398 |
| Jul 7, 2017 | ICU The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a Terminated |
FRN | K070398 |
| Jul 7, 2017 | ICU The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a Terminated |
FRN | K070398 |
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