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) |
|---|---|---|---|
| Jul 24, 2017 | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. Terminated |
FPA | K013871 |
| Jul 24, 2017 | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M Terminated |
FPA | K060944 |
| Jun 30, 2017 | CareFusion 303, Inc. VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200
Product Usage:
Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or Terminated |
FPA | K945070 |
| Jun 19, 2017 | ConMed Corporation STAT 2 I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2 Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2) Terminated |
FPA | K964844 |
| May 15, 2017 | Smiths Medical ASD Inc. CADD High Volume Administration Set with FlowStop, 21-7381-24.
Product Usage:
The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid deliver from an IV b Terminated |
FPA | K031361 |
| Apr 10, 2017 | B Braun Medical Inc CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case) Terminated |
FPA | K112636 |
| Mar 30, 2017 | Smiths Medical ASD Inc. CADD Administration Set, 21-7339-24, Rx Only, Sterile EO. Terminated |
FPA | K040636 |
| Mar 29, 2017 | Angiodynamics Inc. (Navilyst Medical Inc.) NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005 Terminated |
FPA | K852140 |
| Feb 28, 2017 | CareFusion 303, Inc. MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C
The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or cathete Terminated |
FPA | K051499 |
| Feb 28, 2017 | CareFusion 303, Inc. MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305 Terminated |
FPA | K051499 |
| Feb 20, 2017 | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. AMS-636, 60" Microbore extension set.
Product Usage:
Accessory devices used to administer medical fluids. Terminated |
FPA | K021395 |
| Jan 10, 2017 | Bard Access Systems SafeStep Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep trays per case and 100 per carton.
Product Usage:
Inten Terminated |
FPA | K040527 |
| Jan 10, 2017 | Bard Access Systems MiniLoc Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc trays per case and 160 per carton.
Product U Terminated |
FPA | K050600 |
| Jan 10, 2017 | ICU Medical, Inc. Tego Connector, Item No. D1000, NM1000
The Tego Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intr Terminated |
FPA | K053106 |
| Dec 23, 2016 | Becton Dickinson & Company BD FlowSmart Set MiniMed Pro-set Rx Only
Distributed by Medtronic MiniMed Inc.
8006464633
8185765555
Legal Manufacturer
Becton, Dickinson and Company
USA
BD Medical-Diabetes Care
Becton Dickins Terminated |
FPA | K160651 |
| Dec 9, 2016 | Smiths Medical ASD Inc. Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide. Terminated |
FPA | K933390 |
| Nov 21, 2016 | Merit Medical Systems, Inc. Custom Fluid Management Set, Sterile, EO, Rx Only
Used to transfer contrast media and saline from a container to a patients
vascular system. Terminated |
FPA | K915678 |
| Nov 18, 2016 | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651
Product Usage:
Accessory devices used to administer medical fluids. Terminated |
FPA | K021395 |
| Nov 17, 2016 | CareFusion 303, Inc. SmartSite Add-On Bag Access Device, Model No. 10013365 Terminated |
FPA | K970485 |
| Sep 27, 2016 | Zyno Medical LLC Zyno Medical Administration Set Sterile. Rx
For Use with Zyno Medical Infusion Pumps or Gravity Feed
Product Code: B2-70072-F
Product Usage:
Zyno Medical Administration Set is a device used to adminis Terminated |
FPA | K132841 |
| Sep 27, 2016 | Zyno Medical LLC Zyno Medical Administration Set, Sterile. RX
For Use with Zyno Medical Infusion Pumps or Gravity Feed
Product Code: B2-70071-DF
Product Code: B2-70071-DF-120 (expanded recall)
Product Usage:
Zyno Med Terminated |
FPA | K132841 |
| Sep 27, 2016 | Zyno Medical LLC Zyno Medical Administration Set, Sterile. Rx
For Use with Zyno Medical Infusion Pumps or Gravity Feed
Product Code: A2-80072-F
Product Usage:
Zyno Medical Administration Set is a device used to admini Terminated |
FPA | K132841 |
| Sep 27, 2016 | Zyno Medical LLC Zyno Medical Administration Set, Sterile. Rx
For Use with Zyno Medical Infusion Pumps or Gravity Feed
Product Code: A2-80071-DF
Product Code: A2-80071-DF-120 (Expanded recall)
Product Usage:
Zyno Med Terminated |
FPA | K132841 |
| Jun 14, 2016 | WalkMed Infusion, LLC T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a Terminated |
FPA | K073444 |
| Jun 14, 2016 | WalkMed Infusion, LLC T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or cat Terminated |
FPA | K073444 |
| Jun 14, 2016 | WalkMed Infusion, LLC T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter Terminated |
FPA | K073444 |
| Jun 14, 2016 | WalkMed Infusion, LLC T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter Terminated |
FPA | K073444 |
| Jun 14, 2016 | WalkMed Infusion, LLC T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a containe Terminated |
FPA | K073444 |
| Jun 14, 2016 | WalkMed Infusion, LLC T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle o Terminated |
FPA | K073444 |
| Jun 14, 2016 | WalkMed Infusion, LLC T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter in Terminated |
FPA | K073444 |
| Jun 14, 2016 | WalkMed Infusion, LLC T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter insert Terminated |
FPA | K073444 |
| Jun 14, 2016 | WalkMed Infusion, LLC T095-022, IV Set with 0.22 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter inse Terminated |
FPA | K073444 |
| Jun 14, 2016 | WalkMed Infusion, LLC T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through Terminated |
FPA | K073444 |
| Jun 14, 2016 | WalkMed Infusion, LLC T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient Terminated |
FPA | K073444 |
| Jun 14, 2016 | WalkMed Infusion, LLC T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle o Terminated |
FPA | K073444 |
| Jun 14, 2016 | WalkMed Infusion, LLC T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter inserted in Terminated |
FPA | K073444 |
| Jun 14, 2016 | WalkMed Infusion, LLC T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter Terminated |
FPA | K073444 |
| Jun 14, 2016 | WalkMed Infusion, LLC Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter inserted into Terminated |
FPA | K073444 |
| Apr 22, 2016 | Smiths Medical ASD, Inc. CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-733 Terminated |
FPA | K040636 |
| Feb 23, 2016 | Centurion Medical Products Corporation Convenience Kits from Centurion that contain an In-Vision-
Plus Needleless IV Connector, Model: code RYM5001
InVision-Plus Needless IV Connectors are used for single patient use in IV and blood admin Terminated |
FPA | None listed |
| Feb 15, 2016 | CareFusion 303, Inc. Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007 Terminated |
FPA | K944320 |
| Feb 3, 2016 | Global Healthcare Inc ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China Terminated |
FPA | K083687 |
| Jan 21, 2016 | Rymed Technologies, LLC InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use.
Products are intended for single patient use in intravenous and blood administration sets without the need Terminated |
FPA | K093489 |
| Jan 21, 2016 | Rymed Technologies, LLC InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use
Products are intended for single patient use in intravenous and blood administration sets without the need for n Terminated |
FPA | K991653 |
| Dec 17, 2015 | CareFusion 303, Inc. Alaris Pump SmartSite Infusion Set, Model No. 2420-0500.
Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. Terminated |
FPA | K944320 |
| Nov 30, 2015 | Baxter Healthcare Corp. Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s,
Product Usage:
C8581: For the administration of fluids from a container into the patient Terminated |
FPA | K860272 |
| Nov 30, 2015 | Baxter Healthcare Corp. Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433,
Product Usage:
C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device. Terminated |
FPA | K860272 |
| Nov 5, 2015 | CareFusion 303, Inc. SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. Terminated |
FPA | K960280 |
| Oct 16, 2015 | Baxter Healthcare Corp ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT Terminated |
FPA | K132734 |
| Jun 19, 2015 | Unomedical As Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset
Used in combination with infusion pumps for continuous subcutaneous infusion of medication. Terminated |
FPA | K120395 |
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