Panels › General Hospital › Product code FRN · Class 2
Pump, Infusion
Regulation 880.5725
2510(k)s in 12 months (849 all time)
24recalls in 12 months (724 all time)
672recalls that name a 510(k)
Top companies in FRN
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp | 51 | 128 |
| Hospira, Inc. | 12 | 129 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 78 |
| Abbott Laboratories | 67 | 4 |
| Carefusion 303, Inc. | 4 | 61 |
| Icu Medical, Inc. | 4 | 43 |
| Smiths Medical Asd, Inc. | 1 | 42 |
| B.Braun Medical, Inc. | 11 | 22 |
| Y | 26 | 0 |
| Zevex International, Inc. | 0 | 25 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Epidural OB Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user acce Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Non-DEHP Epidural Yellow Striped Tubing Administration Set with Vented Vial Spike and 0.2 Micron Filter Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administration Set with Female Male Luer Locks and Y-Site with Check Valve Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Se Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administration Set with Non-Vented Spike and Y-Site with Checked Valve Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets a Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Curlin administration set with vented spike, 0.2 micron filter, and check valve
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Non-DEHP Administration Set with Non-Vented Spike and 0.2 Micron Filter
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Non-DEHP Administration Set with Non-Vented Spike and 1.2 Micron Filter and Check Valve Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Non-DEHP Administration Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessorie Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Epidural Administration Set with 150 mL Bag and 0.2 Micron Filter Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, pro Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Epidural Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accesso Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administration Set with Female Luer Adapter Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provid Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a Terminated |
FRN | K981816 |
| Mar 14, 2012 | Smiths Medical ASD, Inc. Smiths Medical, Medfusion 3500 Syringe Pumps, Software version 5.0.0, Rx Only.
These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood o Terminated |
FRN | K040899 |
| Feb 29, 2012 | B. Braun Medical, Inc. B. Braun Infusomat Space Pump - US Version Infusion pump. Model number 8713050U. Terminated |
FRN | K062700 K083689 |
| Jan 26, 2012 | CareFusion 303, Inc. Alaris PC unit model 8015.
The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. Terminated |
FRN | K051641 |
| Jan 13, 2012 | Baxter Healthcare Corp. Baxter Colleague 3 Triple Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8153. Product Usage: Intended for use in a Terminated |
FRN | K063696 |
| Jan 13, 2012 | Baxter Healthcare Corp. Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161. Product Usage: Inte Terminated |
FRN | K063696 |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161. Terminated |
FRN | K063696 |
| Oct 28, 2011 | Baxter Healthcare Corp. Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8064.
The Flo-Gard Volumetric Infusion Pumps are an electromechanical Terminated |
FRN | K915523 |
| Oct 18, 2011 | B Braun Medical, Inc Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system i Terminated |
FRN | K011975 K994375 |
| Oct 4, 2011 | Hospira Inc. Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005
Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric ther Terminated |
FRN | K081412 |
| Oct 4, 2011 | Hospira Inc. Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software ve Terminated |
FRN | K031185 K042081 +1 |
| Oct 4, 2011 | Hospira Inc. Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391 - Terminated |
FRN | K011442 K042081 +2 |
| Oct 3, 2011 | B Braun Medical, Inc Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES
B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006
The Outlook ES pump is intended for Terminated |
FRN | K011975 K994375 |
| Sep 29, 2011 | Hospira Inc. Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005.
Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion P Terminated |
FRN | K081412 |
| Sep 29, 2011 | Hospira Inc. Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations:
a) list 12348 - software version 10.3;
b) list 12618 - software Terminated |
FRN | K031185 K042081 +1 |
| Sep 29, 2011 | Hospira Inc. Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations:
a) list 11971
b) list 11973 - software version 10.3
c) list 1239 Terminated |
FRN | K011442 K042081 +2 |
| Aug 31, 2011 | Hospira Inc. GemStar Li-Ion Docking Station; a lithium ion battery powered docking station for use with GemStar Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; List Numbers 13075-04-01, 13075-04-03, 13075-04 Terminated |
FRN | K042980 |
| Aug 11, 2011 | Baxter Healthcare Corp. Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Deerfield, IL. Product Code: 2M8161.
Intended for use in a wide variety of patient environm Terminated |
FRN | K063696 |
| Aug 11, 2011 | Baxter Healthcare Corp. Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Deerfield, IL; product code 2M8161 Terminated |
FRN | K063696 |
| Aug 8, 2011 | Baxter Healthcare Corp. Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161.
Product Usage: I Terminated |
FRN | K063696 |
| Jul 19, 2011 | Baxter Healthcare Corp. Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161.
Product Usage: Intended for use in a Terminated |
FRN | K063696 |
| Jul 13, 2011 | Baxter Healthcare Corp. Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2 M8153 and 2M8163.
Intended for use Terminated |
FRN | K063696 |
| May 19, 2011 | Baxter Healthcare Corp. Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161 an Terminated |
FRN | K063696 |
| Apr 29, 2011 | Baxter Healthcare Corp. Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063
The Flo-Gard Volumetric Infusion Pumps are an electromechanica Terminated |
FRN | K915522 |
| Apr 15, 2011 | Hospira Inc. GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; Hospira, Inc., Lake Forest, IL 60045; list 13092-04-01
A stand-alone PC application for administration of medications s Terminated |
FRN | K083019 |
| Apr 5, 2011 | Zevex International, Inc. Curlin PainSmart IOD Ambulatory Infusion Pump
Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Terminated |
FRN | K981816 |
| Apr 5, 2011 | Zevex International, Inc. Curlin PainSmart Ambulatory Infusion Pump
Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Terminated |
FRN | K981816 |
| Apr 5, 2011 | Zevex International, Inc. Curlin 6000 IOD Ambulatory Infusion Pump
Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Terminated |
FRN | K981816 |
| Apr 5, 2011 | Zevex International, Inc. Curlin 6000 CMS Ambulatory Infusion Pump
Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Terminated |
FRN | K981816 |
| Mar 16, 2011 | Hospira Inc. Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015.
The Hospira Symbiq Infusion Syste Terminated |
FRN | K041550 K110901 |
| Mar 16, 2011 | Hospira Inc. Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015.
The Hospira Symbiq Infusion Syste Terminated |
FRN | K041550 K110901 |
| Mar 14, 2011 | Hospira Inc. Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005
The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace a Terminated |
FRN | K081412 |
| Mar 14, 2011 | Hospira Inc. Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations:
a) list 12348 - software version 10.3;
b) list 12618 - software Terminated |
FRN | K031185 K042081 +1 |
| Mar 14, 2011 | Hospira Inc. Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations:
a) list 11971
b) list 11973 - software version 10.3
c) list 12391 Terminated |
FRN | K011442 K042081 +2 |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511089001.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps.
Made in Germany
Terminated |
FRN | K100704 |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510937001. AC FLEXLINK PLUS SET 10/100 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage Terminated |
FRN | K100704 |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510953001. AC FLEXLINK PLUS SET 10/70 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage Terminated |
FRN | K100704 |
| Mar 10, 2011 | Roche Insulin Delivery Systems Inc. ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510945001. AC FLEXLINK PLUS SET 10/40 10PK.
An infusion set for the subcutaneous infusion of insulin administered with micro dosage i Terminated |
FRN | K100704 |
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