Not applicable

Clinical Chemistry and Clinical Toxicology Devices

1

No

US Nationwide Distribution

cobas 8000 Modular Analyzer Series || c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer || Product Usage: || The VS II system is a stand-alone, computer-controlled instrument designed to aliquot patient sample from a primary tube to a barcoded secondary tube for processing on an off-line analyzer.

Lot #'s: 73D1600174, 73D1600587, 73E1600661, 73F1600015, 73G1600729, 73H1600012, 73H1600149, 73H1600341, 73H1600902, 73J1600062, 73L1600025, 73L1600210, 73L1600445, 73M1500036, and 73M1500036

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US including AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV Internationally to United Arab Emirates, Vienna, Australia, Belgium, Switzerland, China, Germany, Czech Republic, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iran, Italy, Japan, South Korea, R¿publique du Liban, Netherlands, Norway, Qatar, Romania, Saudi Arabia, Republic of Singapore, Turkey, Taiwan, and South Africa

Percuvance Maryland Dissector Tool Tip || The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.

Lot Numbers: 101219, 103102, 105025, 106337, 109045, 110699, 111198, K110057, K110924, K124484, K128817, K132629, K141382, K144904, K147200, K148053, K157883, K160686, K163440, K189808, K211510, K221874, K511628 4950-17

Anesthesiology Devices

2

No

Nationwide

4950-16 Portex¿ Epidural Mini-pack

Lot numbers 20187, 20502, 22697, and 24264

General and Plastic Surgery Devices

2

No

Distribution was made to LA, MS, and TX.

regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. || Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot number 2627353, part number 020-052-01

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide to Al, AZ, CA, CN, DE, FL, GA, IL, IN, KT, KY, LA, MA, MD, MI, MN, MS, MO, NE, NJ, NM, and TX.

LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package, || Distributed and Manufactured by: LifeScan, Inc., || 1000 Gibraltar Drive, Milpitas, CA 95037

Lot numbers: C523029789, D113032927, D333038386, D113032982, D093032541 and D243033308.

Orthopedic Devices

1

No

Worldwide distribution: USA including states of: AZ, CA, FL, GA, IL, IN, LA, MA, and MI; and countries of: Australia, Belgium, England, France, Italy, Japan, South Africa, Spain and Sweden.

***REF MCA7-2SB***2 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** || Lot numbers: C523029789, D113032927, D333038386, D113032982, D093032541 and D243033308. || Intended usage: Cutting and shaping bone including bones of the spine and cranium.

None as the product is software

Radiology Devices

2

No

Nationwide Distribution-including the states of AL, CA, DC, KS, LA, MO, NB, NY, NC, ND, OH, OR, PA, RI, SC, TX, and WA.

Oncentra External Beam 4.1. || Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.

R4.2, R5.0, R5.1, R6.0, R6.1

Radiology Devices

2

No

Worldwide Distribution - USA including AL, CA, CT, GA, FL, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, NJ, NY, OH, PA, TN, TX, VA, and Internationally to Argentina, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cuba, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Lebanon, Mexico, Morocco, Netherland, Nigeria, Pakistan, Panama, Peru, Philippines, Portugal, Russia, Serbia, Solvenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, and Yemen.

RT Desktop || The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Start SN and Date: 06020101 Feb 2006 End SN and Date 10080662 Aug 2010

Hematology and Pathology Devices

2

No

Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Brunei, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Quatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Venezuela, Vietnam.

ACL TOP CTS, automated coagulation laboratory instrument.

Serial Numbers: 1005, 1065, 1076, 1112, 1202, 1242, 1269, 1278, 1279, and 1282.

Radiology Devices

2

No

Nationwide Distribution, including states of AL, MO, NC, NY, OH, OR, TN, and TX.

Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical Solutions, Malvern, PA 19355

106623, 106624, 106625, 106626, 106627, 106628 110405 and 110423.

Orthopedic Devices

1

No

US, Australia, Canada, Mexico, Chile, Japan.

Modular Microplasty Cup impactor 1/4" - 28 thread insert , REF 31-400605

BATCHES 2009092550, 2009111850, 2009121150, 2009122150, 2010032550, 2010040550, 2010050450, 2010052850 AND 2010082650.

General and Plastic Surgery Devices

2

No

Nationwide Distribution

Material CVI2880, PICC LINE KIT, CENTURION PICC LINE KIT, REORDER CVI2880, STERILE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com || FACILITATES PICC LINE PLACEMENT

Identified by B.40 firmware

Immunology and Microbiology Devices

1

No

Worldwide Distribution - USA including AR, AZ, CA, FL, KS, LA, MD, MN, MT, NC, NV, NY, OR, PA, RI, SC, TX, VA and WA. Internationally to Argentina, Armenia, Austria, Bangladesh, Bosnia and Herzegowina, Brazil, Bulgaria, Burkina FASO, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, COTE DIVOIRE, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA, MALTA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UNITED STATES, URUGUAY, VENEZUELA, VIETNAM, PALESTINE, AND SERBIA.

bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument || The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.

Site numbers: 530664, 519535, 532292, 533551, 538806, 532150, 504797, 504807, 504730, 533418, 536796, 534743, 532178, 520525, 504798, 504806, 534681, 534731, 536899, 522418, 536641, 533897, 534221, 505651, 530391, 530390, 532074, 535931, 536646, 539094, 522162, 536007, 535979, 536138, 504659, 536136, 540048, 539628, 519533, 535946, 533796, 538234, 504666, 531830, 505861, 505860, 540237, 506564, 536592, 532532, 536067, 505587, 535274, 532227, 535278, 520309, 537386, 537630, 506148, 530666, 521320, 521892, 530667, 533763, 530392, 533762, 538902, 531837, 531834, 520814, 537357, 521548, 534218, 521589, 105784, 536433, 536234, 530669, 532244, 520524, 521463, 535367, 521890, 520755, 520523, 532245, 535285, 534678, 536717, 532264, 534217, 506621, 530370, 538369, 534682, 530368, 534215, 530460, 505805, 534810, 535951, 538406, 538744, 538476, 538903, 537065, 534477, 534479, 536163, 534478, 536014, 104925, 534476, 532294, 522253, 520236, 519812, 504750, 536154, 536155, 530715, 535728, 534639, 535727, 534638, 538482, 538512, 506049, 536777, 104149, 531948, 519594, 519771, 531760, 535793, 533283, 519677, 533284, 538514, 506658, 533278, 533282, 506657, 533287, 533286, 533285, 534232, 506654, 522245, 506047, 506170, 532533, 532614, 520809, 532616, 506178, 532535, 535813, 532534, 532617, 532613, 534856, 532615, 532246, 521763, 539204, 522138, 520632, 535342, 531806, 504747, 531805, 521545, 521537, 533738, 532799, 532215, 522038, 521315, 520630, 104954, 535566, 104958, 531961, 538102, 538538, 103711, 535439, 104952, 537020, 534798, 521314, 520631, 104956, 104957, 104955, 522440, 506322, 105656, 105655, 537985, 104075, 531944, 521312, 534796, 535424, 540421, 105670, 522135, 531943, 521311, 505759, 104514, 104515, 521675, 104670, 531945, 535376, 536901, 521802, 520251, 506616, 506403, 531942, 530584, 531957, 531817, 531813, 506785, 538464, 521318, 522293, 504940, 538516, 534876, 521512, 532446, 531946, 505925, 533343, 520491, 534246, 531949, 532445, 505968, 536178, 538269, 535667, 531951, 536715, 536090, 535702, 534452, 534255, 505707, 522247, 522243, 520481, 522250, 505679, 531931, 506476, 505106, 505668, 532249, 536789, 505107, 537804, 535927, 531753, 535615, 534813, 531752, 538485, 538486, 538228, 521650, 520977, 538466, 534233, 105674, 537024, 521711, 534724, 533967, 105940, 505486, 104642, 539220, 105390, 519901, 521820, 519213, 538028, 533476, 534420, 534158, 520783, 530421, 531728, 537698, 520793, 104890, 532080, 533966, 536028, 533955, 536034, 536031, 536042, 532077, 536035, 533956, 536037, 534730, 533401, 105960, 538771, 534150, 519738, 534787, 534630, 520681, 500038, 534152, 506637, 535418, 520431, 520004, 504665, 520660, 519214, 521659, 535779, 105947, 535415, 535396, 519541, 521854, 520761, 536171, 103128, 506370, 105912, 519548, 534431, 538368, 520680, 534569, 506230, 105615, 506232, 536174, 519576, 536798, 534160, 536379, 534237, 519211, 520430, 540841, 539479, 539107, 506717, 538465, 536993, 537784, 535814, 505572, 521853, 500028, 500029, 522065, 520948, 520882, 506169, 519115, 532652, 522177, 532649, 537205, 505719, 504789, 534716, 504493, 504792, 532990, 535614, 534717, 506408, 519733, 534758, 534440, 519680, 534811, 540622, 522191, 534374, 535224, 522397, 506397, 519899, 538386, 519894, 105136, 533395, 505254, 505989, 540082, 500042, 519195, 105081, 105082, 105186, 533236, 537266, 519198, 535492, 520779, 533772, 532611, 533922, 537073, 531651, 532986, 532612, 522119, 532263, 535400, 522118, 105140, 105191, 505809, 533085, 533084, 103562, 537118, 506538, 105598, 102948, 103265, 534427, 531808, 103561, 531762, 540288, 537934, 538193, 538157, 506540, 506539, 532262, 520956, 103331, 530485, 505876, 103564, 539099, 104464, 533619, 103780, 102499, 540016, 537805, 102560, 538813, 105779, 521661, 533861, 103781, 535635, 522458, 535611, 533543, 519537, 532225, 519534, 504770, 537597, 538479, 534250, 539322, 521770, 521769, 105157, 505281, 521222, 535173, 534545, 534380, 538194, 535202, 537644, 534565, 533857, 536471, 535250, 536639, 534270, 534268, 536173, 537466, 534108, 521154, 534874.

Radiology Devices

2

No

Devices were distributed nationwide to hospitals/medical centers.

AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version.

All Serial Numbers.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide:Distributed to hospitals/laboratories in IL, PA, TN, TX, UT, VA and WV.

Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL