ClearanceBrief
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)
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Top companies in FPA

DateFirm and productCodeLinked 510(k)
Oct 27, 2010Baxter 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
FPAK964918
Oct 27, 2010Baxter 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
FPAK781036
Oct 27, 2010Baxter 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
FPAK781036
Oct 27, 2010Baxter 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
FPAK962581
Oct 27, 2010Baxter 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
FPAK913627
Oct 27, 2010Baxter 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
FPAK811078
Oct 27, 2010Baxter 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
FPAK003225
Oct 15, 2010Baxter 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
FPAK984381
Sep 29, 2010Hospira 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
FPAK060806
Sep 29, 2010Hospira 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
FPAK060806
Sep 29, 2010Hospira 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
FPAK060806
Sep 29, 2010Hospira 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
FPAK060806
Sep 29, 2010Hospira 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
FPAK060806
Sep 29, 2010Hospira 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
FPAK060806
Sep 29, 2010Hospira 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
FPAK060806
May 21, 2010Churchill 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
FPAK011336
Apr 15, 2010Hospira 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
FPAK033576
Apr 15, 2010Hospira 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
FPAK780880
Apr 15, 2010Hospira 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
FPAK063239
Apr 15, 2010Hospira 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
FPAK063239
Apr 15, 2010Hospira 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
FPAK920736
Apr 15, 2010Hospira 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
FPAK912103
Apr 15, 2010Hospira 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
FPAK033576
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK033576
Apr 15, 2010Hospira 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
FPAK033576
Apr 15, 2010Hospira 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
FPAK033576
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK890282
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK030002
Apr 15, 2010Hospira 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
FPAK770183

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