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Diagnostic Equipment

🏥 Medical Devices • 6,554 recalls

HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

HemoCue AB

Class I - Dangerous

During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.

Jul 15, 2013 Diagnostic Equipment Nationwide View Details →

"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.

Edwards Lifesciences

Class I - Dangerous

The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on top of the Tyvek instead of being placed at the bottom of the box. There is no evidence available at this time that could validate the sterility of this incorrect packaging configuration.

Jul 31, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →

LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number: LG100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

Genzyme Corporation, A Sanofi Company

Class I - Dangerous

Product contains particulates (fibers)

Jun 21, 2013 Diagnostic Equipment Nationwide View Details →
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