Panels › General Hospital › Product code FPA · Class 2
Set, Administration, Intravascular
Regulation 880.5440
6510(k)s in 12 months (1,176 all time)
110recalls in 12 months (1,090 all time)
1,030recalls that name a 510(k)
Top companies in FPA
| Company | 510(k)s | Recalls |
|---|---|---|
| B.Braun Medical, Inc. | 23 | 234 |
| Baxter Healthcare Corp | 67 | 151 |
| Icu Medical, Inc. | 27 | 187 |
| Hospira, Inc. | 14 | 109 |
| Smiths Medical MD, Inc. | 4 | 37 |
| Churchill Medical Systems, Inc. | 7 | 32 |
| CME America, LLC | 0 | 38 |
| Abbott Laboratories | 30 | 0 |
| Y | 28 | 0 |
| Carefusion, Inc. | 1 | 25 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2009 | B. Braun Medical, Inc. Ultrasite IV Administration Set with Universal Spike, three Backcheck Valves, three Ultrasite Injection Sites and Spin-Lock Connector, Catalog #470007.
For use with Secondary Container. Terminated |
FPA | K955585 |
| Jun 5, 2009 | B. Braun Medical, Inc. Primary IV Set with Universal Spike, Backcheck Valve, 3 Ultrasite Injection Sites and Spin-Lock Connector, Catalog # 375100.
For use with Secondary Container. Terminated |
FPA | K955585 |
| Jun 5, 2009 | B. Braun Medical, Inc. Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, Backcheck Valve, and Spin-Lock Connector, Catalog # 352520.
For us Terminated |
FPA | K904518 K955585 |
| Jun 5, 2009 | B. Braun Medical, Inc. IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck Valve and Spin-Lock Connector, Catalog # 352049.
For use with Secondary Container. Terminated |
FPA | K955585 |
| Apr 20, 2009 | Smiths Medical MD, Inc. CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO.
CADD Medication Cassette Reservoirs are intended for use with the CADD Amb Terminated |
FPA | K843772 |
| Oct 24, 2008 | B. Braun Medical, Inc. Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5 in. The product is shipped 100 units per carton. Terminated |
FPA | K955585 |
| Sep 23, 2008 | B. Braun Medical, Inc. Burette Set w/150 ml burette w/15 um filter & inj site, inj site, with automatic shutoff 87 in. Item/Catalog number 375113. The product is shipped 20 units per carton. The product is for use after ac Terminated |
FPA | K781744 K921860 |
| Sep 23, 2008 | B. Braun Medical, Inc. Add-On Burette Set with 150 ml burette 7 Ultrasite Injection Site with automatic shutoff, 20 in US1525M Metriset Add-on Burette Set. Item/Catalog number 375059. The product is shipped 20 units per car Terminated |
FPA | K781744 K790062 +1 |
| Sep 23, 2008 | B. Braun Medical, Inc. Add-On Burette Set with 150 ml burette and Ultrasite Injection Site without automatic shutoff. Item/Catalog number 375111. The product is shipped 20 units per carton. The product is for use after act Terminated |
FPA | K781744 K790062 +1 |
| Sep 23, 2008 | B. Braun Medical, Inc. Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 in US1540. Item/Catalog number 375137. The product is shipped 20 units per carton. The product is for use afte Terminated |
FPA | K781744 K921860 +1 |
| Sep 23, 2008 | B. Braun Medical, Inc. Metriset Burette Set w/Horizon Pump, Ultrasites, 120 in. Item/Catalog number 375150. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlo Terminated |
FPA | K781744 K904518 +1 |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K10-01795DP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra Terminated |
FPA | K915678 |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K09-01280JP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra Terminated |
FPA | K915678 |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K09-09051P, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contras Terminated |
FPA | K915678 |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K09-09938P, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contras Terminated |
FPA | K915678 |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K09-02842CP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra Terminated |
FPA | K915678 |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K09-05971AP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra Terminated |
FPA | K915678 |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K09-05785FP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra Terminated |
FPA | K915678 |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fluid Administration Set, Custom Kit, REF: K09-05336DP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra Terminated |
FPA | K915678 |
| Feb 13, 2008 | Smiths Medical MD, Inc. Smiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 100 ml, Reorder No. 21-7300-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112 Terminated |
FPA | K040636 |
| Nov 8, 2007 | Cardinal Health 303 Inc DBA Alaris Products Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA. Terminated |
FPA | K053049 |
| Aug 30, 2007 | Smiths Medical MD, Inc. Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC
4695-24A, REF 21-7002-24, Sterile EO, Made in Mexico Smith Medical MD, Inc. St Paul, MN 5 Terminated |
FPA | K843772 |
| Aug 30, 2007 | Smiths Medical MD, Inc. Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 50 ml PC
4694-24A, REF 21-7001-24, Sterile, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112 Terminated |
FPA | K843772 |
| Aug 30, 2007 | Smiths Medical MD, Inc. Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF 21-7100-24, Sterile, Made in Mexico Smith Medical MD, Inc. St Paul, M Terminated |
FPA | K843772 |
| Aug 22, 2007 | Carmel Pharma, Inc. PhaSeal, Protector 50, Item No. 50, US Order No. 10310 Terminated |
FPA | K001368 |
| Aug 22, 2007 | Carmel Pharma, Inc. PhaSeal, Protector 21, Item No. 21, US Order No. 22020 Terminated |
FPA | K001368 |
| Aug 22, 2007 | Carmel Pharma, Inc. PhaSeal Injector Luer Lock, Item No. 31, US Order No. 10310 Terminated |
FPA | K001368 |
| Aug 22, 2007 | Carmel Pharma, Inc. PhaSeal, Protector 14, Item No. P14, US Order No. 21320 Terminated |
FPA | K001368 |
| Aug 18, 2007 | Arizant Healthcare, Inc Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24250. For use with a Ranger warming unit. Terminated |
FPA | K973741 |
| Aug 18, 2007 | Arizant Healthcare, Inc Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24200. For use with a Ranger warming unit. Terminated |
FPA | K973741 |
| Aug 16, 2007 | ICU Medical, Inc. Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291 Terminated |
FPA | K033290 |
| Aug 7, 2007 | Curlin Medical Llc Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets. Terminated |
FPA | K981816 |
| May 31, 2007 | B. Braun Medical, Inc. Horizon Pump Metriset Burette Set. The product is shipped in cases containing 20 sets. Terminated |
FPA | K904518 K955585 |
| May 31, 2007 | B. Braun Medical, Inc. Ultrasite Horizon Pump IV Set. The product is shipped in cases containing 24 sets. Terminated |
FPA | K904518 K955585 |
| Mar 14, 2007 | Baxter Healthcare Corp. Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer lock adapter; for us Terminated |
FPA | K981792 |
| Mar 14, 2007 | Baxter Healthcare Corp. Baxter Interlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer loc Terminated |
FPA | K981792 |
| Mar 14, 2007 | Baxter Healthcare Corp. Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP 12 inch pump segment, 0.22 micron downstream high pressure filter, Luer activated valve, Terminated |
FPA | K003225 K981792 |
| Feb 27, 2007 | Hospira Inc. LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light R Terminated |
FPA | K830014 |
| Dec 30, 2006 | Rymed Technologies, Inc. RYM-5001 InVision-Plus Neutral Displacement I.V. Connector, packaged 100 units per box, 5 boxes per case (500 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Terminated |
FPA | K991653 |
| Dec 30, 2006 | Rymed Technologies, Inc. RYM-5000 InVision-Plus NEUTRAL I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin Terminated |
FPA | K991653 |
| Dec 30, 2006 | Rymed Technologies, Inc. RYM-5000 InVision-Plus Neutral Displacement I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Terminated |
FPA | K991653 |
| Dec 6, 2006 | Smiths Medical ASD, Inc. Level 1 Normothermic I.V. Fluid Administration Set
REF DI-60HL
(Foreign Distribution Only) Terminated |
FPA | BK860023 |
| Dec 6, 2006 | Smiths Medical ASD, Inc. Level 1 Normothermic I.V. Fluid Administration Set
REF D-60HL Terminated |
FPA | BK860023 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Minivolume Extension Set, product code JC9944; An Rx sterile, nonpyrogenic fluid pathway, 8'', 0.4 mL Vol., with Luer Activated Valve; Baxter Corporation, Toronto, Ontario, Canada; Made in Cana Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8740; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 1.0 mL Vol., with injection site, 0.22 Micron Downstream Filter and male Luer Terminated |
FPA | K925126 K964850 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Clearlink System Non-DEHP Minivolume Extension Set, product code 1C8739; An Rx sterile, nonpyrogenic fluid pathway, 8.0'', 0.6 mL Vol., with Luer Activated Valve for IV Access and male Luer Loc Terminated |
FPA | K003225 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Clearlink System Non-DEHP Minivolume Extension Set, product code 1C8705; An Rx sterile, nonpyrogenic fluid pathway, 7.0'', 0.33 mL Vol., with Luer Activated Valve for IV Access and male Luer Lo Terminated |
FPA | K003225 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Y-Type Minivolume Extension Set, product code 1C8689; An Rx sterile, nonpyrogenic fluid pathway, 6.0'', 0.33 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 6 Terminated |
FPA | K811078 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.8 mL Vol., with 2 injection sites and male Luer Lock adapter; Baxter H Terminated |
FPA | K925126 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System 3-Lead Extension Set, product code 1C8442; An Rx sterile, nonpyrogenic fluid pathway, 6'', 1.6 mL Vol., with 2 Interlink Injection Sites and a Male Luer Lock adapter; Baxter He Terminated |
FPA | K915390 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.