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) |
|---|---|---|---|
| Oct 22, 2010 | Hospira Inc Hospira brand Symbiq One-Channel Infuser
LIST No. 16026 Symbiq One-Channel Infuser,
List Number Configurations:
16026-04-01/03/04,51/52, 53/54, 79/80, 81/82, 83/84, 87/88 and 89/90,
16026-13-25/26, 5 Terminated |
FRN | K041550 |
| Oct 20, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 blockAid 400 mL Painpump for continuous Nerve Block, REF 575-100, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI. Terminated |
FRN | None listed |
| Oct 20, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 400 mL Painpump with Luer Lock Tubing Set, REF 540-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI. Terminated |
FRN | None listed |
| Oct 20, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 250 mL Painpump with Luer Lock Tubing Set, REF 525-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI. Terminated |
FRN | K042405 K043466 |
| Oct 13, 2010 | CareFusion Corporation CareFusion Alaris PC Unit Model 8015 (formerly Medley
PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December
20, 2008 and May 6, 2009 Terminated |
FRN | K051641 |
| Oct 12, 2010 | Baxter Healthcare Corp. Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163. Terminated |
FRN | K063696 |
| Oct 12, 2010 | Baxter Healthcare Corp. Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161. Terminated |
FRN | K063696 |
| Sep 28, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 BlockAid Demo 400 mL PainPump for Continuous Nerve Block, Non-sterile Not for surgical use, REF 575-100S1, Stryker Instruments, Kalamazoo, MI.
Delivers controlled amounts of medi Terminated |
FRN | K042405 K043466 |
| Sep 28, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 BlockAid 400 mL PainPump for Continuous Nerve Block, sterile, REF 575-100, Stryker Instruments, Kalamazoo, MI.
Delivers controlled amounts of medication and narcotics. Terminated |
FRN | K042405 K043466 |
| Sep 28, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 400 mL PainPump with Luer Lock Tubing Set, sterile, REF 540-350, Stryker Instruments, Kalamazoo, MI.
Delivers controlled amounts of medication and narcotics. Terminated |
FRN | K042405 K043466 |
| Sep 28, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 250 mL PainPump with Luer Lock Tubing Set, sterile, REF 525-350, Stryker Instruments, Kalamazoo, MI.
Delivers controlled amounts of medication and narcotics. Terminated |
FRN | K042405 K043466 |
| Sep 9, 2010 | Hospira Inc Hospira brand Symbiq Two-Channel Infuser,
LIST No. 16027 Symbiq Two-Channel Infuser,
List Number Configurations:
16027-04-01/03/04, 51/52, 53/54, 79/80,81/82,83/84,87/88 and 89/90 16026-27-89/90,
1 Terminated |
FRN | K041550 |
| Sep 9, 2010 | Hospira Inc Hospira brand Symbiq One-Channel Infuser
LIST No. 16026 Symbiq One-Channel Infuser,
List Number Configurations:
16026-04-01/03/04,51/52, 53/54, 79/80, 81/82, 83/84, 87/88 and 89/90,
16026-13-25/26, 5 Terminated |
FRN | K041550 |
| Sep 8, 2010 | Hospira Inc Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027 respectively. Terminated |
FRN | K041550 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker Pain Pump 2 Luer Cap, REF 525-401, Rx, Sterile, Product of Ireland Manufactured for Stryker Instruments Kalamazoo MI Terminated |
FRN | K043405 |
| Aug 17, 2010 | Hospira Inc. Hospira Accessory Power Pack; a 4 outlet power strip with a custom pole clamp bracket to attach to the IV pole with the infusion pump; Distributed by: Hospira, Inc., 275 N. Field Drive, Lake Forest, I Terminated |
FRN | None listed |
| Aug 2, 2010 | CareFusion Corporation Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module Terminated |
FRN | K051641 |
| Aug 2, 2010 | Smiths Medical ASD, Inc. MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in critical care areas for the administrati Terminated |
FRN | K040899 |
| Jul 2, 2010 | Hospira Inc Hospira brand Symbiq Two-Channel Infuser; List Number: 16027; Distributed by: Hospira, Inc. Morgan Hill, CA and Manufactured by: Hospira Inc, La Aurora, Heredia, Costa Rica.
Intended for the delive Terminated |
FRN | K041550 |
| Jul 2, 2010 | Hospira Inc Hospira brand Symbiq One-Channel Infuser; List Number: 16026; Distributed by: Hospira, Inc. Morgan Hill, CA and Manufactured by: Hospira Inc, La Aurora, Heredia, Costa Rica.
Intended for the delivery Terminated |
FRN | K041550 |
| Apr 5, 2010 | Smiths Medical ASD, Inc. CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump,
REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112. Terminated |
FRN | K982838 |
| Jan 15, 2010 | Smiths Medical ASD, Inc. Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA) Terminated |
FRN | K040899 |
| Jan 15, 2010 | Smiths Medical ASD, Inc. Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6. Model 3500. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA). Terminated |
FRN | K040899 |
| Oct 6, 2009 | Hospira Inc Plum XL3D, list #s 11855-04-01, 11855-04-03, 11855-04-05, 11855-04-07; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K010924 |
| Oct 6, 2009 | Hospira Inc Plum XLM, list #s 11846-04-03, 11846-04-05, 11846-04-07; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K952799 |
| Oct 6, 2009 | Hospira Inc Plum XL3M, List numbers 11845-04-03, 11845-04-05, 11845-04-07, 11845-04-11, 11845-04-13; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K952799 |
| Oct 6, 2009 | Hospira Inc Plum XL 3, list #s 11781-04-01, 11781-04-03, 11781-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K010924 |
| Oct 6, 2009 | Hospira Inc Plum XLD, list numbers 11859-04-01, 11859-04-03, 11859-04-05, 11859-04-07, 11859-04-09, 11859-04-11, 11859-04-13, 11859-04-51, 12570-04-01 (veterinary); AC cord manufactured by Electri-Cord, Westfield Terminated |
FRN | K010924 |
| Oct 6, 2009 | Hospira Inc Plum XL, list numbers 11555-04-01, 11555-04-03, 11555-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K010924 |
| Oct 6, 2009 | Hospira Inc Plum A+ Infusion System with Hospira Mednet, list #s 20679-04-01, 20679-04-03, 20679-04-05, 20679-04-51, 20679-04-77, 20679-04-79, 20679-04-81, 20792-04-01, 20792-04-03, 20792-04-05, 20792-04-51, 2079 Terminated |
FRN | K042081 |
| Oct 6, 2009 | Hospira Inc Plum A+3 Infusion System with Hospira Mednet, list # 20678-04-01, 20678-04-03, 20678-04-51, 20678-04-77, 20678-04-81, 20678-04-05, 20678-04-53; AC cord manufactured by Electri-Cord, Westfield PA, Infu Terminated |
FRN | K042081 |
| Oct 6, 2009 | Hospira Inc Plum A+3 v.11.X, list #s 12618-04-01, 12918-04-03, 12618-04-05, 12618-04-51, 12618-04-07, 12618-04-53; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morga Terminated |
FRN | K052052 |
| Oct 6, 2009 | Hospira Inc Plum A+ v.10.3, list #s 11971-04-01, 11971-04-03, 11971-04-05, 11971-04-07, 11971-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K011442 |
| Oct 6, 2009 | Hospira Inc Plum A+ v.11.X, list #s 12391-04-01, 12391-04-03, 12391-04-05, 12391-04-11, 12391-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K070398 |
| Oct 6, 2009 | Hospira Inc Plum A+3, list #s 12348-04-03, 12348-04-05, 12348-04-07, 12348-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K021350 |
| Oct 6, 2009 | Hospira Inc Plum A+ Infusion System (veterinary), list #s 60529-04-01, 60529-04-03, 60529-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | None listed |
| Oct 6, 2009 | Hospira Inc Plum LifeCare 5000 (Plum 1.6) with Dataport, list #s 02507-04-11, 02507-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K911401 |
| Oct 6, 2009 | Hospira Inc Omniflow 4000 Plus, List numbers 40051-04-05, 40051-04-07, 40051-04-09, 40051-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K882594 |
| Oct 6, 2009 | Hospira Inc Nutrimix Micro Compounder, List #s 11365-04-01, 11365-04-03, 11365-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K921365 |
| Oct 6, 2009 | Hospira Inc LifeCare PCA with Hospira Mednet, list numbers 20709-04-01, 20709-04-03, 20709-04-51, 20709-04-53, 20709-04-77; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospi Terminated |
FRN | K042800 |
| Oct 6, 2009 | Hospira Inc LifeCare PCA 3, list #s 12384-04-01, 12384-04-03, 12384-04-05, 12384-04-07, 12384-04-09, 12384-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Terminated |
FRN | K022203 |
| Oct 6, 2009 | Hospira Inc LifeCare PCA Plus II, list #01950-04-03, 01950-04-05, 01950-04-07, 01950-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K912928 |
| Oct 6, 2009 | Hospira Inc GemStar Docking Station (90-260 volts), list numbers 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Mor Terminated |
FRN | K060806 |
| Oct 6, 2009 | Hospira Inc GemStar AC Wall (Mains) adapter, 90-260 volts, universal, list # 13072-04-01, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K060806 |
| Oct 6, 2009 | Hospira Inc Flexiflo Quantum Enteral Pump, List number 50596, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K944669 |
| Oct 6, 2009 | Hospira Inc Acclaim Encore Infusion Pump, List # 12569-04-03 (veterinary), 12237 04-15, 12273-04-51, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | K011096 |
| Oct 6, 2009 | Hospira Inc AC Power Cords, shipped between 06/2005 and 05/2009. These cords were used in the following infusion pump models: Nutrimix, Q-Vue, Q2, Q2 Plus, Ox4, PCA, PCA II, PCA 3, Lifecare PCA, Lifecare 4100, Terminated |
FRN | None listed |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump ExFen, 10.0 in. dual site antimicrobial silver ExFen catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-210-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump ExFen, 5.0 in. dual site antimicrobial silver ExFen catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-205-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump ExFen, 2.5 in. dual site antimicrobial silver ExFen catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-202-000. Terminated |
FRN | K042405 K043466 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.