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) |
|---|---|---|---|
| Feb 13, 2008 | Smiths Medical MD, Inc. Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 50 ml, Reorder No. 21-7001-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112 Terminated |
FRN | K843772 |
| Jan 4, 2008 | Cardinal Health 303 Inc DBA Alaris Products Cardinal Health Alaris Pump Module (formerly Medley Pump Module), Model 8100, Cardinal Health, San Diego, CA. (All Alaris Pump modules shipped prior to December 23, 2007 are subject to this recall) Terminated |
FRN | None listed |
| Sep 19, 2007 | Baxter Healthcare Corp. Baxter Colleague CX Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product code 2M8161 Terminated |
FRN | K063696 |
| Aug 3, 2007 | Cardinal Health 303 Inc DBA Alaris Products Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013 Terminated |
FRN | K872764 |
| Aug 2, 2007 | Cardinal Health 303 Inc DBA Alaris Products All IV Administration Infusion Sets intended for use with the Gemini Infusion Pump and Alaris Pump module (a.k.a. Medley Pump module) including: Alaris SmartSite Low Sorbing Set, Alaris Vented Syring Terminated |
FRN | K862295 |
| Jul 28, 2007 | Baxter Healthcare Corp. Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; Product codes 2M8153 and 2M8163 ( Terminated |
FRN | K063696 |
| Jul 28, 2007 | Baxter Healthcare Corp. Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; Product codes 2M8151 and 2M8161 ( Terminated |
FRN | K063696 |
| Jul 28, 2007 | Baxter Healthcare Corp. Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product code # 2M8064 Terminated |
FRN | K915523 |
| Jul 28, 2007 | Baxter Healthcare Corp. Baxter Flo-Gard 6201, SIngle Channel , Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063 Terminated |
FRN | K915522 |
| Jul 18, 2007 | Baxter Healthcare Corp. Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8163, 2M9 Terminated |
FRN | K063696 |
| Apr 26, 2007 | Smiths Medical MD, Inc. Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4. Medex, 4350 Green Parkway, Suite 200. Duluth, GA 30096 Terminated |
FRN | K982640 |
| Apr 5, 2007 | Smiths Medical MD, Inc. Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP). Smiths Medical MD Terminated |
FRN | K000842 K960826 +1 |
| Mar 20, 2007 | Baxter Healthcare Corp. Baxter Flo-Gard 6300 Dual Channel Volumetric Infusion Pump, catalog #2M8048, 2M8048R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FRN | K910934 |
| Mar 20, 2007 | Baxter Healthcare Corp. Baxter Flo-Gard 6200 Volumetric Infusion Pump, catalog #2M8043, 2M8043R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FRN | K913895 |
| Mar 20, 2007 | Baxter Healthcare Corp. Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FRN | K915523 |
| Mar 20, 2007 | Baxter Healthcare Corp. Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FRN | K915522 |
| Jan 11, 2007 | Baxter Healthcare Corp. Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8153R, 2M Terminated |
FRN | K041191 |
| Jan 11, 2007 | Baxter Healthcare Corp. Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, 2M Terminated |
FRN | K041191 |
| Nov 16, 2006 | Sorenson Medical, Inc. ambIT Ambulatory Infusion Pump Cassette; Filterless, Male, Sterile, Vol. 2.3ml, REF 220267, Sorenson Medical, Inc., West Jordan, Utah. Terminated |
FRN | K002434 K033325 +1 |
| Nov 16, 2006 | Sorenson Medical, Inc. ambIT Ambulatory Infusion Pump Cassette; Filter, Male, Sterile, Vol. 2.3ml, REF 220266, Sorenson Medical, Inc., West Jordan, Utah. Terminated |
FRN | K002434 K033325 +1 |
| Nov 16, 2006 | Sorenson Medical, Inc. ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, Sorenson Medical, Inc., West Jordan, Utah. Terminated |
FRN | K002434 K033325 +1 |
| Nov 16, 2006 | Sorenson Medical, Inc. ambIT Ambulatory Infusion Pump Cassette; Filterless, Spike, Sterile, Vol. 2.3ml, REF 220139, Sorenson Medical, Inc., West Jordan, Utah Terminated |
FRN | K002434 K033325 +1 |
| Sep 19, 2006 | Cardinal Health 303 Inc DBA Alaris Products Alaris SE Pump (formerly Signature Edition Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232 Terminated |
FRN | K012383 K022209 +3 |
| Aug 26, 2006 | Delphi Medical Systems Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8. Terminated |
FRN | K953896 |
| Jul 1, 2006 | Sorenson Medical, Inc. ambIT Ambulatory Infusion Therapy Intermittent Pump Terminated |
FRN | K033425 |
| May 17, 2006 | Excelsior Medical Corp ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excelsior Medical Corporation, Neptune, NJ. Terminated |
FRN | K914988 |
| Mar 16, 2006 | Baxter Healthcare Corp. Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A. Terminated |
FRN | K945942 |
| Mar 7, 2006 | Baxter Healthcare Corp. Baxter Auto Syringe AS40 and AS40A Infusion Pump, product code 1M8565 (pumps with drug library option) and product codes 1M8560 and 1M8560R (pumps without drug library option); Baxter Healthcare Corpo Terminated |
FRN | K940147 |
| Jan 31, 2006 | Baxter Healthcare Corp. Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8153R, BR Terminated |
FRN | K041191 |
| Jan 31, 2006 | Baxter Healthcare Corp. Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, BR Terminated |
FRN | K041191 |
| Jan 28, 2006 | Baxter Healthcare Corp. Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Manufactured Terminated |
FRN | K002679 |
| Jan 28, 2006 | Baxter Healthcare Corp. Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Manufactured Terminated |
FRN | K002679 |
| Jan 12, 2006 | Hospira Inc Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04;
Hospira brand Plum A+I.V. Infusion Pump, List No. 12391-04;
Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12618-04;
Hospira brand Plu Terminated |
FRN | None listed |
| Nov 18, 2005 | Baxter Healthcare Corp. Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A. Terminated |
FRN | K945942 |
| Nov 16, 2005 | Abbott Laboratories Fleixiflo Quantum Enteral Pump. Terminated |
FRN | K944669 |
| Nov 16, 2005 | Baxter Healthcare Corp. Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FRN | K993387 |
| Sep 28, 2005 | Baxter Healthcare Corp. Epidural Infusion Pumps sold under the following labels;
a) Baxter 6060E Epidural Infusion Pump, product code 2L9351, 2L9351P and 2L9351R; Manufactured by an affiliate of Baxter Healthcare Corp., Deer Terminated |
FRN | K002679 K941984 |
| Sep 23, 2005 | Baxter Healthcare Corp. Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8153, 2M8153R, 2M8163, 2M8163R Terminated |
FRN | K041191 |
| Sep 23, 2005 | Baxter Healthcare Corp. Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8151, 2M8151R, 2M8161, 2M8161R Terminated |
FRN | K041191 |
| Sep 21, 2005 | Baxter Healthcare Corp. Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished), 2M8064G, 2M8064U, 2M8064F, 2M8064A, 2M8064D & 2M8064B; Baxter Healthcare Corporation, Deerfield, IL Terminated |
FRN | K915522 |
| Sep 21, 2005 | Baxter Healthcare Corp. Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished), 2M8063G (global), 2M8063U, 2M8063F, 2M8063A, 2M8063D & 2M8063B; Baxter Healthcare Corporation, Deerfield, IL 6001 Terminated |
FRN | K915522 |
| Aug 10, 2005 | Baxter Healthcare Corp. Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8153R, 2M Terminated |
FRN | K041191 |
| Aug 10, 2005 | Baxter Healthcare Corp. Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, 2M Terminated |
FRN | K041191 |
| Aug 6, 2005 | Baxter Healthcare Corp. Baxter 6060E Epidural Infusion Pump, product code 2L9351 and 606000-40EL; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore Terminated |
FRN | None listed |
| Aug 6, 2005 | Baxter Healthcare Corp. Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832, 606000-40, 606000-40L, 606000-40I; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore Terminated |
FRN | K002679 |
| Jul 21, 2005 | Baxter Healthcare Corp. Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8153R, 2M8163, 2 Terminated |
FRN | K041191 |
| Jul 21, 2005 | Baxter Healthcare Corp. Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2 Terminated |
FRN | K041191 |
| May 13, 2005 | Medrad Inc Continuum MR Compatible Infusion Pump. Pump Model #3009135 Terminated |
FRN | K021988 K032771 |
| Apr 27, 2005 | Baxter Healthcare Corp. Configuration Transfer Cable; an accessory for the Colleague Infusion pump, Product code 2M8155; Baxter Healthcare Corporation, Deerfield, IL Terminated |
FRN | None listed |
| Apr 22, 2005 | Baxter Healthcare Corp. Baxter Lock Box for 250 mL Container, for use with 6060 Pump Family; Baxter product code 2L9363 and previously marketed by Sabratek under product code 606160, Baxter Healthcare Corporation, Deerfield Terminated |
FRN | K002679 |
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