All lot codes

Cardiovascular Devices

3

No

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

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.

All lot codes

Cardiovascular Devices

3

No

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

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.

All lot codes

Cardiovascular Devices

3

No

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

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.

All lot codes

Cardiovascular Devices

3

No

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

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.

All lot codes

Cardiovascular Devices

3

No

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

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.

see letter | all

MD: Intravascular occluding solution kit

Model Catalog: 50089773 (Lot serial: 40C028); Model Catalog: 50090424 (Lot serial: 40C028); Model Catalog: 50089773 (Lot serial: 41C028); Model Catalog: 50090424 (Lot serial: 41C028); Model Catalog: 50089773 (Lot serial: 40C029); Model Catalog: 50090424 (Lot serial: 40C029); Model Catalog: 50089773 (Lot serial: 40C033); Model Catalog: 50090424 (Lot serial: 40C033); Model Catalog: 50089773 (Lot serial: 40C034); Model Catalog: 50090424 (Lot serial: 40C034); Model Catalog: 50090424 (Lot serial: 41C032); Model Catalog: 50089773 (Lot serial: 41C032)

CLIKSTAR INSULIN INJECTION PEN

Model Catalog: (Lot serial: )

OPTIPEN PRO

Model Catalog: (Lot serial: "AA" THROUGH "SI"); Model Catalog: (Lot serial: "A" THROUGH "S"); Model Catalog: (Lot serial: ALL)

ONE TOUCH ULTRA BLOOD GLUCOSE MONITOR

Model Catalog: (Lot serial: ALL LOT NUMBERS)

ICY HOT HEAT THERAPY

Only those Aspercreme units that have the "bonus packs" containing any lot of the Icy Hot Heat Therapy patches.

Physical Medicine Devices

1

No

Worldwide - USA, Canada, and Honduras

Aspercreme, Pain Relieving Creme with Aloe, Maximum Strength Formula, Net Wt 3oz (85g) with Bonus Icy Hot Heat Therapy Air Activated Heat Patch, 1 individually wrapped patch, 3.9" x 5.3" (10cm x 13.5cm), Distributed by Chattem, Inc. P.O. Box 2219, Chattanooga, TN 37409-0219

All Lots

Physical Medicine Devices

1

No

Worldwide - USA, Canada, and Honduras

Icy Hot Heat Therapy , Air Activated Heat Patch, Arm, Neck and Leg and Small Areas, UPC Code 0-41167-08335-2, Product Code 08335, 3.9" x 5.3" (10cm x 13.5 cm) each, 1 and 4 count patches, Distributed by Chattem, Inc. P.O. Box 2219, Chattanooga, TN 37409-0219

Lot Numbers Affected: RM00654  RM00664  RM00672  RM00687  RM00690  RM00698  RM00700  RM00711  RM00714  RM00727  RM00732  RM00741  RM00748  RM00757  RM00773  RM00781  RM00791  RM00802 RM00820 RM00835

General and Plastic Surgery Devices

2

No

Nationwide

Genzyme Biosurgery Essentials Kit, Item Number 82004

Worldwide distribution.

Diamigo i-Phone App || The Diamigo app was intended for use as an educational tool in the management of diabetes.

LeGoo Endovascular Occlusion Gel