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Showing 65741–65760 of 68218 results

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Merit Medical Systems, Inc: Merit Custom Procedure Kit

Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.

FDASep 2, 2005MD, OR, VA +1 more• Merit Medical Systems, Inc

Medtronic Emergency Response Systems, Inc.: QUIK-COMBO pacing/defibrillation/ECG (therapy) cables use...

Potential for voltage pins in connector of therapy cable to break.

FDASep 2, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Alcon Research, Ltd: Lasik Custom Pak containing 1 dual tip irrigator, 8 ports...

Unknown residue noted on suface of flap irrigators incorporated into cusom paks.

FDASep 2, 2005LA• Alcon Research, Ltd

B. Braun Medical, Inc.: 7F Locking Tearaway Introducers non-sterile. Part number ...

Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR).

FDASep 1, 2005Nationwide• B. Braun Medical, Inc.

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 4 inch diameter Roller P...

The pump may stop during the autodose delivery without completion of the dose delivery to the patient.

FDASep 1, 2005Nationwide• Terumo Cardiovascular Systems Corp

Power Surgical Solutions: Medtronic Midas Rex Classic, GS and Legend dissecting too...

Potential compromise of sterile packaging for disposable dissecting tools.

FDASep 1, 2005Nationwide• Power Surgical Solutions

AGA Medical Corporation: AMPLATZER Vascular Plug, Manufactured by AGA Medical Corp...

Five lots of AMPLATZER Vascular Plugs were sterilized in a load that was not validated for the AMPLATZER Vascular Plug. However, only three of those five lots were distributed.

FDASep 1, 2005Nationwide• AGA Medical Corporation

Medtronic Cardiac Surgery Technologies: Medtronic SPYDER Anastomotic Device. Sterilized using ir...

Customers stated that the U-Clip deployment collar was either difficult to rotate or 'locks up' during usage, which prevents the deployment of the U-Clips.

FDASep 1, 2005Nationwide• Medtronic Cardiac Surgery Technologies

Smiths Medical PM, Inc.: Advisor Vital Signs Monitor (model 9200), catalog number ...

Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor.

FDASep 1, 2005AZ, CA, KS +4 more• Smiths Medical PM, Inc.

Enpath Medical, Inc.: Enpath Steerable Sheath, model 10775-003, Sterile EO. Si...

Enpath has become aware that some of the Enpath Medical 8 Fr Steerable sheath devices may have non-conforming hemostasis valves in that the valve can leak or the valve was observed to have a small hole.

FDAAug 31, 2005MA• Enpath Medical, Inc.

Ethicon, Inc US: J-VAC Reservoir is a component of the J-VAC Closed Wound ...

Two lots of J-VAC Drain Reservors were shipped to Japan prior to sterilization and were released.

FDAAug 31, 2005IN• Ethicon, Inc US

Remington Medical Inc.: Model 6149 Pacing Vector Selector Cable Switch for use wi...

The vector selector has an electrical design flaw which prevents RV pacing.

FDAAug 31, 2005MN• Remington Medical Inc.

Nichols Institute Diagnostics: Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) As...

Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.

FDAAug 31, 2005Nationwide• Nichols Institute Diagnostics

Nichols Institute Diagnostics: Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay...

Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.

FDAAug 31, 2005Nationwide• Nichols Institute Diagnostics

Abbott Diabetes Care, Inc.: FreeStyle CoPilot Web Based Data Management System, and F...

Downloadable software obtained from the firm's website displays user data (including but not limited to insulin levels and pump statistics data) in a matter that may be misinterpreted and result in mistreatment of therapy.

FDAAug 30, 2005OR• Abbott Diabetes Care, Inc.

Linvatec Corp.: ConMed Linvatec MicroChoice Footswitch and ConMed linvate...

The footswitch may develop a system fault resulting in the self-activation of the handpiece it controls, or it may cause the handpiece to run intermittently or to revert to a default setting.

FDAAug 30, 2005Nationwide• Linvatec Corp.

Baxter Healthcare Renal Div: Accura System for Blood Filtration, product codes 5M5660 ...

A software anomaly that occurs when the Reset Totals option is selected during CVVHD therapy with a diaylsate flow rate of less than 600 mL/hour, or CVVH therapy with a predilution flow rate of less than 600 mL/hour, causes balance alarms without an obvious cause.

FDAAug 29, 2005Nationwide• Baxter Healthcare Renal Div

Baxter Healthcare Corp. Rt.: Baxter''s Patient Care System (BPCS) software, Pharmacy M...

If an administrative user modifies any of the seven pre-defined Monitoring Parameters when they are attached to a medication in the drug file, a Point of Care end user will be unable to enter monitoring parameter results on the handheld.

FDAAug 29, 2005CA, MA, MO +1 more• Baxter Healthcare Corp. Rt.

Stryker Howmedica Osteonics Corp.: Meridian PA Femoral Stem

The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.

FDAAug 24, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Oasis Medical Inc: OASIS Medical Vidaurri LASIK Flap Irrigator, Product Spec...

"Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators

FDAAug 24, 2005Nationwide• Oasis Medical Inc

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