Lot#1008419

Ear, Nose, and Throat Devices

2

No

Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom

BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO || The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.

Begining Lot 1207251, Ending Lot Code 1207251; Beginning Lot Code 1209171, Ending Lot Code 1210151. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the month, and 1 is the Manufacturing Shift Code (1, 2, 3, 4, 5, 6 or 9).

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - USA including CA , FL, IA, IN, MA, MD, ME, MO, MS, NC, NM, OH, PA, TX. Foreign distribution to Spain, Portugal, Japan and Hungary.

WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central or Peripheral Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices.

Beginning Lot Code 1209171, Ending Lot Code 1210101. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the month, and 1 is the Manufacturing Shift Code (1, 2, 3, 4, 5, 6 or 9).

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - USA including CA , FL, IA, IN, MA, MD, ME, MO, MS, NC, NM, OH, PA, TX. Foreign distribution to Spain, Portugal, Japan and Hungary.

WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central, Mediastinal and Hilar Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices.

Begining Lot 11207241, Ending Lot Code 1207251; Beginning Lot Code 1209171, Ending Lot Code 1210081. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the month, and 1 is the Manufacturing Shift Code (1, 2, 3, 4, 5, 6 or 9).

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - USA including CA , FL, IA, IN, MA, MD, ME, MO, MS, NC, NM, OH, PA, TX. Foreign distribution to Spain, Portugal, Japan and Hungary.

WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needles, Central, Carinal and Mediastinal Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices.

Beginning Lot Code 1209171, Ending Lot Code 1209201. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the month, and 1 is the Manufacturing Shift Code (1, 2, 3, 4, 5, 6 or 9).

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - USA including CA , FL, IA, IN, MA, MD, ME, MO, MS, NC, NM, OH, PA, TX. Foreign distribution to Spain, Portugal, Japan and Hungary.

WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices.

Part Number: 98-0034; Serial Numbers: C25302189205, C26302224202, C25302189204, C25302067902, C26302224204, C27302202503, C28302328702, C25302189204, C25302127005, C25302067902, C26302224202, C25302141301, C25302189201, C28302328705, C25302127003, C25302141304.

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** || This device is intended to be used with Anspach Systems

Part Number: 98-0039, 98-0040, 98-0050, 98-0057; Serial Numbers: C06301529106, 200058302, 200058301, 200057701, 200057702, 200058402, 200058401, 200057802, 200057801, C05301514406, C06301529102, C8301529004, C08301529002, C06301529102, C08301529007, C08301529006, C08301529002, 200058301. 200069302, 200069301, D31200076202, D31200076203, D31200076204, D31200076201, D31200079014, D31200079007, D31200079015, D31200079012, D31200079010, D31200079016, D31200079001, D31200079004, D31200079008, D31200079003, D31200079009, D31200079002, D31200079006, D31200079011, D31200079017, D31200079013.

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** || This device is intended to be used with Anspach Systems

Part Number: 98-0042; Serial Numbers: 20069801. 20069802.

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** || This device is intended to be used with Anspach Systems

Product code: BC0524A; All lots manufactured after March 1, 2011

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.

Inspira AIR Balloon Dilation system. || Size 5 x 24 mm, Syringe volume 6-8 cc. || Dilation of airway tree.

Product code: BC0724A; All lots manufactured after March 1, 2011

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.

Inspira AIR Balloon Dilation system. || Size 7 x 24 mm, Syringe volume 6-8 cc. || Dilation of airway tree.

Product code: BC8524A; All lots manufactured after March 1, 2011

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.

Inspira AIR Balloon Dilation system. || Size 8.5 x 24 mm, Syringe volume 12 cc. || Dilation of airway tree.

Product code: BC1040A; All lots manufactured after March 1, 2011

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.

Inspira AIR Balloon Dilation system. || Size 10 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.

Product code: BC1240A; All lots manufactured after March 1, 2011

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.

Inspira AIR Balloon Dilation system. || Size 12 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.

Product code: BC1440A; All lots manufactured after March 1, 2011

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.

Inspira AIR Balloon Dilation system. || Size 14 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.

Product code: BC1640A; All lots manufactured after March 1, 2011

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.

Inspira AIR Balloon Dilation system. || Size 16 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.

Product Catalog Numbers: REF 8229705, 8229706, 8229707, 8229708, 8229709, 8229735, 8229736, 8229737, 8229738, 8229739.  Lot Numbers: 205830052 to 206486732. 0206516104, 0206516105, 0206516106, 0206516108, 0206520224, 0206520225, 0206520226, 0206520227, 0206520228, 0206520358, 0206542163, 0206545356, 0206545502.

Ear, Nose, and Throat Devices

2

No

Worldwide distribution: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, and WA; and countries of : Australia, Canada, Germany, Italy, Norway, Poland and United Kingdom.

REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only || The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.

Serial Number 0214200753

Ear, Nose, and Throat Devices

2

No

Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.

Stryker TPS Universal Driver REF 5100- 99 Rx , || The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.

Serial Number 0326801633, 0330802913, 0406200763, 0410401383, 0410600013, 0534203093,0627600783, 0730101013, 0730101033, 0805000553, 0809829593, 0935603083,1011903103, 1011903493, 1013814003, 1025400463, 1025400643, 1126901343, and 1128022593

Ear, Nose, and Throat Devices

2

No

Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.

CORE Universal Driver REF 5400- 99 Rx Only || This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.

0910505713, 1029801073, 1225400823, 1314201603, 1314300713, 1314300723, 1314300733, 1314300743, 1314300753, 1314300763, 1314300773, 1314300783, 1314300793, 1314300803, 1314300813, 1314300823, 1314300833, 1314300843, 1314300853, 1314300863, 1314300873, 1314300883, 1314300893, 1314300903, 1314804033, 1314900053, 1314906453, 1314908193

Ear, Nose, and Throat Devices

2

No

Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.

RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only || The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric Universal Driver is intended for surgical procedures involving driving wire or pins into bone and hard tissue. This includes but is not limited to Dental, ENT (Ear, Nose, Throat), Neuro, and Endoscopic applications. This device can also be used with the Total Performance System (TPSTM).

LOTS: 1057760, 1057919 and 1059222

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.

Blom-Singer Adjustable Tracheostoma Valve II || Models: BE8025H and BE8025H-R3

ALL LOTS

Ear, Nose, and Throat Devices

2

No

Nationwide Distribution: FL, IL, CA. IN, MI, CA, NJ, TX, NE, NC, OR, PA, TN, DC, UT, CO, MO, KY, MD, WV, NY, and MN.

Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only || MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.

P/N 5290-628-000, Lot #13280CG2

Ear, Nose, and Throat Devices

2

No

US Distribution including the states of NV, CA, WA, TN, OR, SD, ID, IN and CO., and Internationally to Malaysia

2.5MM Aggressive Blade || Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. || ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only || It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.

All Serial Numbers

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution

Anspach MicroMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.

All Serial Numbers

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution

Anspach Xmax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.

Lot Number 58536200.

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution --- including USA and country of Canada. (22 boxes were distributed within U.S. Three boxes were distributed to Medtronic Canada but returned)

VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc. || The Vari-Stim III nerve locator/stimulator is a sterile, single-use disposable, hand-held, battery-operated device intended to stimulate motor nerves exposed during surgery for the purpose of identification or location.