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) |
|---|---|---|---|
| Jan 14, 2020 | CME America, LLC BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA the Terminated |
FPA | K031749 |
| Dec 12, 2019 | Baxter Healthcare Corporation ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Product Usage: intended Open, Classified |
FPA | K961225 |
| Dec 12, 2019 | Baxter Healthcare Corporation Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vascular system through Open, Classified |
FPA | K961225 |
| Nov 20, 2019 | B. Braun Medical, Inc. Safeline Y-Type Blood Set, Catalog Number V2500 Terminated |
FPA | None listed |
| Nov 20, 2019 | B. Braun Medical, Inc. Safeline Y-Type Blood Set, Catalog Number NF5140 Terminated |
FPA | K840212 K931377 |
| Nov 20, 2019 | B. Braun Medical, Inc. Y-Type Blood Set, Catalog Number 490530 Terminated |
FPA | K060231 K140311 +1 |
| Nov 20, 2019 | B. Braun Medical, Inc. Y-Type Blood Set, Catalog Number 490425 Terminated |
FPA | K022895 K083723 +1 |
| Nov 20, 2019 | B. Braun Medical, Inc. Y-Type Blood Set, Catalog Number 490314 Terminated |
FPA | K060231 K083723 +3 |
| Nov 20, 2019 | B. Braun Medical, Inc. Y-Type Blood Set, Catalog Number 490293 Terminated |
FPA | K022895 K083723 +1 |
| Nov 20, 2019 | B. Braun Medical, Inc. Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005 Terminated |
FPA | K140311 K922637 |
| Oct 4, 2019 | ICU Medical, Inc. REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889 Terminated |
FPA | K100576 |
| Sep 23, 2019 | B. Braun Medical, Inc. B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032 Terminated |
FPA | K142036 |
| Aug 20, 2019 | Repro-Med Systems, Inc. 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous
Safety Needle Sets"
Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery of medication to the Terminated |
FPA | K122404 |
| Jul 11, 2019 | Becton Dickinson & Company Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-00 Terminated |
FPA | K894842 |
| Jul 8, 2019 | Smiths Medical ASD Inc. GRIPPER Needles sold individually. Labeled as the following item descriptions:
1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX;
2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX;
3. NDL, GRIPPER, 20G X 1.2 Terminated |
FPA | K870866 |
| Jun 26, 2019 | Becton Dickinson & Company SmartSite Syringe Administration Set-Product Package Size 50,
Catalog Number: 10798696 Terminated |
FPA | K811885 |
| Jun 10, 2019 | Molded Products Inc Luer Lock Set - Catalog # MPC-125, for IV administration sets. Terminated |
FPA | K925927 |
| May 29, 2019 | Zyno Medical LLC Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed
Product Code: B2-70072-F Terminated |
FPA | K132841 |
| May 29, 2019 | Zyno Medical LLC Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed
Product Code:B2-70072 Terminated |
FPA | K132841 |
| May 2, 2019 | Becton Dickinson & Company CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy
Cat. No. MP1000-C Terminated |
FPA | K083472 |
| Apr 15, 2019 | ICU Medical, Inc. SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets.
The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer Terminated |
FPA | None listed |
| Apr 15, 2019 | ICU Medical, Inc. icumedical ChemoLock Closed Vial Spike w/Skirt,
(a) REF CL-80S-4 (4 units)
(b) REF CL-80S-5 (5 units).
Used in IV administration sets.
The ChemoLock Closed System Drug Transfer Device prevents t Terminated |
FPA | None listed |
| Apr 15, 2019 | ICU Medical, Inc. icumedical ChemoLock, 20mm,
(a) REF CL-80S
(b) REF CL-80S-10 (10 units).
Used in IV administration sets.
The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental con Terminated |
FPA | K131549 |
| Apr 15, 2019 | ICU Medical, Inc. icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV Terminated |
FPA | None listed |
| Apr 15, 2019 | ICU Medical, Inc. icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. Used in IV admini Terminated |
FPA | None listed |
| Apr 15, 2019 | ICU Medical, Inc. icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets.
The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the trans Terminated |
FPA | K081361 |
| Apr 15, 2019 | ICU Medical, Inc. icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets.
The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the tran Terminated |
FPA | K081361 |
| Apr 10, 2019 | Becton Dickinson & Company MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000
MZ1000-07 MZ5301
MZ5302 MZ5303
MZ5304 MZ5305
MZ5306 MZ5307
MZ5309 MZ5310
MZ5312 MZ5313
MZ5316 MZ8001
MZ8002 MZ80 Terminated |
FPA | K171957 |
| Mar 5, 2019 | Becton Dickinson & Company Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07 Terminated |
FPA | K931173 |
| Mar 5, 2019 | Becton Dickinson & Company Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07 Terminated |
FPA | K931173 |
| Dec 6, 2018 | Vygon U.S.A. Vyon DUALSTOP White Cap used for intravascular lines
Product Code: 9888.002- Product Usage: Cap used for intravascular lines. Terminated |
FPA | None listed |
| Dec 6, 2018 | Vygon U.S.A. Vygon DUALSTOP Red Cap used for intravascular lines
Product Code: 9888.00 - Product Usage: Cap used for intravascular lines. Terminated |
FPA | None listed |
| Sep 26, 2018 | Becton Dickinson & Company PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177
Product Usage:
PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for g Terminated |
FPA | K811885 |
| Sep 26, 2018 | Becton Dickinson & Company PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07
Product Usage:
PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for grav Terminated |
FPA | K811885 |
| Sep 7, 2018 | Bayer Medical Care, Inc. Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems
Product Usage:
1.2 micron filter for use with Intravenous Administration Terminated |
FPA | K830755 |
| Jul 5, 2018 | Medtronic Inc. Medtronic MiniMed Paradigm Veo Insulin Pump
Product Catalog Number: MMT-554, MMT-754 Terminated |
FPA | None listed |
| May 9, 2018 | B. Braun Medical, Inc. Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420
The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Va Terminated |
FPA | K142036 |
| Apr 20, 2018 | CareFusion 303, Inc. Alaris Infusion Pump administration sets labeled as:
-Infusion Set
Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP Terminated |
FPA | K894842 |
| Jan 5, 2018 | Repro-Med Systems, Inc. HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS12609, RMS62612, RMS6 Terminated |
FPA | K122404 |
| Nov 10, 2017 | Zevex Incorporated (dba Moog Medical Medical Devices Group) MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port (Positive Pressure), Anti-Siphon Valve include Terminated |
FPA | K981816 |
| Nov 10, 2017 | Zevex Incorporated (dba Moog Medical Medical Devices Group) MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Prot Terminated |
FPA | K981816 |
| Nov 10, 2017 | Zevex Incorporated (dba Moog Medical Medical Devices Group) MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curl Terminated |
FPA | K981816 |
| Nov 10, 2017 | Zevex Incorporated (dba Moog Medical Medical Devices Group) MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, packaged 20/box, for use with the Moog Curlin Ambulatory Volumet Terminated |
FPA | K981816 |
| Nov 10, 2017 | Zevex Incorporated (dba Moog Medical Medical Devices Group) MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (Positive Pressure), packaged 20/box, for use with the Moog Cur Terminated |
FPA | K981816 |
| Nov 10, 2017 | Zevex Incorporated (dba Moog Medical Medical Devices Group) MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with the MOOG Curlin Ambulatory Volumetric Infusion Pump, RX, Steri Terminated |
FPA | K981816 |
| Nov 6, 2017 | CareFusion 303, Inc. Alaris Extension Sets with microbore tubing Model 20022 and 30914
Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's a Terminated |
FPA | K790108 K790582 |
| Sep 10, 2017 | Medtronic Inc. Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T) Open, Classified |
FPA | K160648 |
| Sep 10, 2017 | Medtronic Inc. Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T) Open, Classified |
FPA | K160648 |
| Sep 10, 2017 | Medtronic Inc. Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T) Open, Classified |
FPA | K160648 |
| Sep 10, 2017 | Medtronic Inc. Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T) Open, Classified |
FPA | K160648 |
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