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) |
|---|---|---|---|
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Non-DEHP I.V. Catheter Extension Set, 8.2" (20.9 cm), 0.3 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter; an Rx sterile device; Baxter Healthcare Corpo Terminated |
FPA | K964918 |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Micro-Volume Infusion Set, with 27 G x 0.6" (1.5 cm) Needle, 43" (64 cm), 0.24 mL; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 1M8451
For the administr Terminated |
FPA | K781036 |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Micro-Volume Infusion Set, with 27 G x 0.6" (1.5 cm) Needle, 25" (64 cm), 0.18 mL; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 1M8450
For the administ Terminated |
FPA | K781036 |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Interlink System Non-DHEP Extension Set; 8.3" (21.0 cm), Volume 1.4 mL, Large Bore 3-Way Stopcock with Rotating Male Luer Lock, Injection Site, Male Luer Lock Adapter with Retractable Collar; Terminated |
FPA | K962581 |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Clearlink System Non-DEHP 3 Port Adapter, 1.2 mL, 2 Luer Activated Valves for IV Access, Male Luer Lock Adapter; a sterile Rx device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; pro Terminated |
FPA | K913627 |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Non-DEHP Y-Type Catheter Extension Set, 5.3" (13.5 cm), 1.0 mL, Male Luer Lock Adapter with Retractable Collar; a sterile Rx device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; pro Terminated |
FPA | K811078 |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Clearlink System Non-DEHP Y-Type Catheter Extension Set, 6.5" (16.5 cm), Vol 1.2 mL, Luer Activated Valve for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx sterile device; Terminated |
FPA | K003225 |
| Oct 15, 2010 | Baxter Healthcare Corp. Baxter Interlink System Buretrol Solution Set, 83" (2.1 m), 150 mL Burette Drip Chamber Filter Valve, 2 Injection Sites, Male Luer Lock Adapter, Large Bore 4-Way Stopcock with Rotating Male Luer Loc Terminated |
FPA | K984381 |
| Sep 29, 2010 | Hospira Inc. Gemstar Pump Set with Convertible Pin, Latex-Free set with Attached Pressure-Activated Anti-Siphon Valve, Pump Yellow Striped Tubing-SL, 95 inch; Rx, sterile, 24 individually packaged sets per case; Terminated |
FPA | K060806 |
| Sep 29, 2010 | Hospira Inc. Gemstar Pump Set, LifeShield Latex-Free Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, 3 inch Segment of Clear PVC Tubing, 0.2 Micron Filter, Clave Port-SL, Attached Pressure-Activate Terminated |
FPA | K060806 |
| Sep 29, 2010 | Hospira Inc. Gemstar Pump Set, LifeShield Latex-Free Pump Set with Check Valve, Clave Ports, P.A.V. Secure Lock and Non-DEHP, 59 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, Inc., Lake Fores Terminated |
FPA | K060806 |
| Sep 29, 2010 | Hospira Inc. Gemstar Pump Set-SL, Latex-Free Set with Attached Pressure-Activated Anti-Siphon Valve, Nonvented, 96 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, Inc., Lake Forest, IL 60045 US Terminated |
FPA | K060806 |
| Sep 29, 2010 | Hospira Inc. Gemstar Pump Set-SL, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve, Nonvented, 96 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, Inc., Lake Forest, I Terminated |
FPA | K060806 |
| Sep 29, 2010 | Hospira Inc. Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve, Yellow Striped Tubing-SL, Nonvented, 110 inch; Rx, sterile, 24 individually packaged sets per case; Hospi Terminated |
FPA | K060806 |
| Sep 29, 2010 | Hospira Inc. Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve and Y-Extension with Backcheck Valve-SL, Nonvented, 110 inch; Rx, sterile, 24 individually packaged sets p Terminated |
FPA | K060806 |
| May 21, 2010 | Churchill Medical Systems, Inc. Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical Systems, Inc. Dover, NH 03820.
Intrava Terminated |
FPA | K011336 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Y-Type Blood Set, yellow key slide clamp, 110 inch, nonvented with 170 micron filter, CLAVE port and OPTION-LOK, 10 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Terminated |
FPA | K033576 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Y-Type Blood Set, nonvented, 100 inch with CLAVE and secure lock, 10 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 12450- Terminated |
FPA | K780880 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free Secondary I.V. Set, convertible pin, 34 inch, piggyback with OPTION-LOK, non-DEHP, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa R Terminated |
FPA | K063239 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Secondary I.V. Set, convertible pin, 32 inch, piggyback with drop-in blunt cannula and OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA Terminated |
FPA | K063239 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free Secondary I.V. Set, convertible pin, 32 inch, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list Terminated |
FPA | K920736 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Secondary I.V. Set, convertible pin, 32 inch with OPTION-LOK, drop-in blunt cannula and Snap Lok, 15 drops/mL, a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Terminated |
FPA | K912103 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, backcheck valve, 3 pre-pierced Y-sites, 15 drops/mL, a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa R Terminated |
FPA | K033576 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, CLAVE Y-site, 15 drops/mL, a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica: list 20803-48. Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, backcheck valve, 3 CLAVE Y-sites, 15 drops/mL, a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; l Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, 120 inch, convertible pin, with backcheck valve, 3 CLAVE ports, piggyback with OPTION-LOK, and attached extension set, 15 drops/mL; a Terminated |
FPA | K033576 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, 120 inch, convertible pin, with backcheck valve, 3 CLAVE ports, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device Terminated |
FPA | K033576 |
| Apr 15, 2010 | Hospira Inc. Life shield Latex-Free Primary I.V. Set, yellow key slide clamp, 120 inch, convertible pin, with back check valve, 3 CALV ports, 0.2 micron filter, piggyback with OPTION-LOK, 15 drops/mL; a sterile Rx Terminated |
FPA | K033576 |
| Apr 15, 2010 | Hospira Inc. Lifeshield Latex-Free Primary I.V. Set, yellow key slide clamp, MICRODRIP, backcheck valve, 2 CLAVE Y-sites, 60 drops/mL; a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Cost Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield Latex-Free Primary I.V. Set, yellow key slide clamp, backcheck valve, 2 CLAVE Y-sites,15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Primary I.V. Set, convertible pin, 110 inch with removable 3-port high-flow stopcock manifold, backcheck valve, and 2 CLAVE ports, piggyback with OPTION-LOK, 15 drops/mL, a ste Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Primary I.V. Set, convertible pin, 83 inch, MICRODRIP with OPTION-LOK, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 1 Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. CONTINUUM, Lifeshield, latex-free, Primary I.V. Set, convertible pin, 112 inch with removable 3-port pressure activated valve manifold, backcheck valve and 2 CLAVE ports, piggyback with OPTION-LOK, 15 Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free Primary I.V. Set, convertible pin, 83 inch with backcheck valve and 2 CLAVE ports, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Fore Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Latex-free, Primary I.V. Set, convertible pin, 82 inch with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 19218-48. Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Primary I.V. Set, convertible pin, 100 inch with OPTION-LOK and VENOSET, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free Primary I.V. Set, convertible pin, 110 inch, 0.2 micron filter, CLAVE and OPTION-LOK, with nonphthalate (non-DEHP) tubing and PVC pump segment, 15 drops/mL, a sterile Rx single Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Life shield, latex-free, Primary I.V. Set, convertible pin, 100 inch with CALV and OPTION-LOK, 60 drops/mL, a sterile Rx single use device, Homspera Inc, Lake Forest, IL USA. Made in Costa Rica, list Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Primary I.V. Set, convertible pin, 100 inch with backcheck valve, 3 CLAVE ports, piggyback MICRODRIP with OPTION-LOK, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free Primary I.V. Set, convertible pin, 104 inch with nonphthalate (non-DEHP) tubing, CLAVE and OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve and 3 CLAVE ports, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake For Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve and 2 CLAVE ports, piggyback with high-pressure filter and OPTION-LOK, 15 drops/mL, a sterile Rx single use devi Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve and 2 CLAVE ports, piggyback microdrip with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve and 2 CLAVE ports, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake For Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Primary I.V. Set, convertible pin, 100 inch with CLAVE ports and OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free Primary I.V. Set, convertible pin, 80 inch with backcheck valve and 2 pre-pierced injections sites, MICRODRIP with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospi Terminated |
FPA | K890282 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free Primary I.V. Set, convertible pin, 78 inch with pre-pierced injections sites with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free Primary I.V. Set, convertible pin, 80 inch with backcheck valve and 2 pre-pierced injections sites, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospi Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free Primary I.V. Set, convertible pin, 106 inch with backcheck valve and 3 pre-pierced injections sites, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hosp Terminated |
FPA | K030002 |
| Apr 15, 2010 | Hospira Inc. Latex-free, Primary I.V. Set, vented, 73 inch with flashback bulb, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 8962-48. Terminated |
FPA | K770183 |
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