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) |
|---|---|---|---|
| Nov 7, 2023 | CareFusion 303, Inc. BD Alaris Syringe Module, REF 8110 Open, Classified |
FRN | K051641 K072105 +2 |
| Nov 7, 2023 | CareFusion 303, Inc. BD Alaris PCU REF 8015 Open, Classified |
FRN | K051641 K072105 +2 |
| Oct 25, 2023 | B. Braun Medical, Inc. 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System Open, Classified |
FRN | K142596 K191910 |
| Oct 25, 2023 | B. Braun Medical, Inc. 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System Open, Classified |
FRN | K142596 K191910 |
| Oct 20, 2023 | EITAN MEDICAL LTD Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001) Open, Classified |
FRN | K192860 |
| Oct 6, 2023 | Smiths Medical ASD Inc. Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump Open, Classified |
FRN | None listed |
| Oct 6, 2023 | Smiths Medical ASD Inc. Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump Open, Classified |
FRN | None listed |
| Oct 6, 2023 | Smiths Medical ASD Inc. Medfusion Syringe Pump, Model 4000-XXXX-XX:
a) 0100-50,
b) 0100-249,
c) 0101-50,
d) 0101-51,
e) 0101-78,
f) 0101-249,
g) 0105-51,
h) 0105-78,
i) 0105-249,
j) 0106-00,
k) 0106-01,
l) 0106-23 Open, Classified |
FRN | K111386 |
| Oct 6, 2023 | Smiths Medical ASD Inc. Medfusion Syringe Pump, Model 3500-0600-XX:
a) 0600-00;
b) 0600-01;
c) 0600-50;
d) 0600-51;
e) 0600-82;
f) 0600-249;
software versions: v3, v4, v5, and v6 Open, Classified |
FRN | K040899 |
| Oct 6, 2023 | Smiths Medical ASD Inc. Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6 Open, Classified |
FRN | K040899 |
| Oct 6, 2023 | Smiths Medical ASD Inc. Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 Open, Classified |
FRN | K040899 |
| Sep 25, 2023 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1
Part Number: LVP-SW-0004.
Indicated for use in a hospital and in outpatient care environments for the controlled admin Open, Classified |
FRN | K183311 |
| Aug 18, 2023 | ICU Medical Inc Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 30010 Open, Classified |
FRN | K141789 K161469 |
| Jul 13, 2023 | Baxter Healthcare Corporation The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 Open, Classified |
FRN | K230041 |
| Jul 13, 2023 | Baxter Healthcare Corporation SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 Open, Classified |
FRN | K230022 |
| Jun 6, 2023 | Avanos Medical, Inc. ambIT Cassette Filter Male Luer, Product Code: 220266 Terminated |
FRN | K162165 |
| Jun 6, 2023 | Avanos Medical, Inc. SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568 Terminated |
FRN | K162165 |
| Jun 6, 2023 | Avanos Medical, Inc. SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537 Terminated |
FRN | K162165 |
| Jun 6, 2023 | Avanos Medical, Inc. AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507 Terminated |
FRN | K162165 |
| Jun 6, 2023 | Avanos Medical, Inc. AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509 Terminated |
FRN | K162165 |
| May 16, 2023 | ICU Medical Inc ASM Replacement Battery, Component Number SUB0000594 Open, Classified |
FRN | None listed |
| May 16, 2023 | ICU Medical Inc ASM Replacement Battery, Component Number SUB0000864 Open, Classified |
FRN | None listed |
| May 16, 2023 | ICU Medical Inc Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 1197 Open, Classified |
FRN | K042081 K070398 |
| May 16, 2023 | ICU Medical Inc Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010 Open, Classified |
FRN | K141789 K161469 |
| Apr 18, 2023 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 Open, Classified |
FRN | K183311 |
| Mar 30, 2023 | Iradimed Corporation Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50, Open, Classified |
FRN | K050301 K090087 +1 |
| Mar 1, 2023 | CareFusion 303, Inc. Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255 Open, Classified |
FRN | K072105 |
| Jan 6, 2023 | Bayer Medical Care, Inc. Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile
Catalog number: INT CSS
Affected material number: 86566621
Intended to deliver accurate doses of 18F Fluorode Open, Classified |
FRN | K100798 |
| Nov 21, 2022 | Smiths Medical ASD Inc. Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment.
Used for infusi Open, Classified |
FRN | K111386 |
| Apr 18, 2022 | Smiths Medical ASD Inc. Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500S Open, Classified |
FRN | K040899 |
| Apr 18, 2022 | Smiths Medical ASD Inc. Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4 Open, Classified |
FRN | K111386 |
| Feb 17, 2022 | Smiths Medical ASD Inc. Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main Open, Classified |
FRN | K040899 K111386 |
| Jan 29, 2022 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2. Open, Classified |
FRN | K133801 |
| Jan 29, 2022 | Baxter Healthcare Corporation Baxter Spectrum IQ Infusion Pumps, Product code 3570009. Open, Classified |
FRN | K173084 |
| Oct 19, 2021 | InfuTronix LLC Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP Open, Classified |
FRN | K153193 |
| Oct 19, 2021 | Smiths Medical ASD Inc. CADD-Solis VIP ambulatory infusion pump, Model Numbers:
a. 21-2120-0105-02L
b. 21-2120-0105-03L
c. 21-2120-0105-06L
d. 21-2120-0105-07L
e. 21-2120-0105-08L
f. 21-2120-0105-12L
g. 21-2120-0105-13L
h. 2 Terminated |
FRN | K111275 |
| Aug 11, 2021 | Baxter Healthcare Corporation Dose IQ Safety Software used with Spectrum IQ Infusion Pump Terminated |
FRN | K173084 |
| Aug 6, 2021 | BioMedical Equipment Service Co (BMES) Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410 Terminated |
FRN | K133532 |
| Aug 6, 2021 | Baxter Healthcare Corporation Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids. Terminated |
FRN | K173084 |
| May 10, 2021 | STEP-HAR MEDICAL LLC Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part Terminated |
FRN | K133532 |
| Apr 2, 2021 | Tenacore LLC Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 Terminated |
FRN | K133532 |
| Apr 2, 2021 | Tenacore LLC Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part Terminated |
FRN | K133532 |
| Mar 26, 2021 | Infusion Pump Repair Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part Open, Classified |
FRN | K133532 |
| Mar 25, 2021 | The Biomed Guys Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel. Open, Classified |
FRN | K133532 |
| Mar 24, 2021 | Pacific Medical Group Inc. Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions) Open, Classified |
FRN | K133532 |
| Mar 19, 2021 | Baxter Healthcare Corporation Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids. Terminated |
FRN | K173084 |
| Mar 3, 2021 | CareFusion 303, Inc. BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439. Open, Classified |
FRN | K133532 |
| Jan 6, 2021 | Baxter Healthcare Corporation Infusion Pump Terminated |
FRN | K042121 K133801 +1 |
| Nov 23, 2020 | Baxter Healthcare Corporation Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids. Open, Classified |
FRN | K173084 |
| Nov 23, 2020 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids. Open, Classified |
FRN | K133801 |
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