2008T machines: 190766 2008T Hemodialysis System w/Bibag 190895 2008T GEN 2 Bibag without CDX  190766 = 00840861100910 (+Serial Number) 190895 = 00840861100927 (+Serial Number)ux=&Su;

Gastroenterology-Urology Devices

2

No

US Nationwide Distribution

2008T, Hemodialysis Delivery System || Product Indicated for acute and chronic dialysis therapy.

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. XL-HD.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

20.2cm Heavy Duty Long Heavy Short Attachment

Product Code: V20LC; Lot/Serial Numbers: BB09213 & BB09205

Ophthalmic Devices

1

No

Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan.

20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens || For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

Lot Numbers: 07BHU0004E, 07CHU0010E, 07DHU0025D, 07DHU0025E, 07LHU0004J, 07LHU0004K, 07LHU0004L, 07LHU0004M ,08AHU0004J, 08BHU0019G, 08BM20807A, 08CHU0016G, 08CHU0018F, 08FM15736B, 08JHU0008B, 08LHU0020G, 08MHU0026C, 09BHU0031E, 09BHU0031F, 09BHU0031G, 09CHU0044D, 09DHU0019, 09DHU0019B, 09DHU0036, 09DHU0036C, 09DHU0036D, 09DHU0036E, 09DHU0036F, 09EHU0003, 09EHU0003A, 09EHU0003B, 09EHU0003C, 09EHU0003D, 09EHU0003E, 09EHU0003F, 09EHU0007, 09EHU0007A, 09EHU0007B, 09EHU0007C, 09EHU0007D, 09EHU0013, 09EHU0013A, 09EHU0013B, 09EHU0013C, 09EHU0013D, 09EHU0013E, 09EHU0013F, 09FHU0005, 09FHU0005A, 09FHU0033, 09FHU0033B, 09FHU0033C, 09FHU0033D, 09FHU0033F, 09FHU0033G, 09FHU0033H, 09GM06174A, 09GM14035, 09HHU0008, 09HHU0010, 09HHU0010A, 09HHU0010B, 09HHU0010C, 09HHU0010D, 09HHU0010E, 09HHU0010F, 09HM12199, 09HM12202, 09HM17431, 09KHU0001, 09KHU0001A, 09KHU0001B, 09KHU0001C, 09KHU0001D, 09KHU0001E, 09KHU0001G, 09KHU0001H, 09KHU0001P, 09KHU0010, 09KHU0010A, 09KHU0010B, 09LM10792, 09MM01112A, 10AM02971, 10BHU0007, 10BHU0007A, 10BHU0007B, 10BHU0007C, 10BHU0007D, 10BHU0007F, 10BHU0007G, 10BHU0010, 10BHU0010A, 10BHU0010M, 10BHU0018, 10BHU0018A, 0BHU0018B, 10BHU0018C, 10BHU0018D, 10BHU0018E, 10BHU0018F, 10EHU0013, 10EHU0013A, 10EHU0013B, 10FM16220, 11CHU0015A, 11CHU0015B, 11CHU0015C, 11DHU0003, 11DHU0003A, 11DHU0005, 11DHU0005A, 11DHU0005B, 11HHU0027, 11HHU0030, 11HHU0031, 11HHU0031B, 11HHU0032, 11HHU0034, 11JHU0006, 11JHU0007, 11JHU0008, 11JHU0009, 11JHU0010, 11JHU0024, 11JHU0024A, 11KHU0007, 11KHU0016, 11LHU0004, 11LHU0005, 11LHU0005A, 11LHU0007, 11LHU0008, 11LHU0011, 11LHU0011A, 11LHU0012, 11LHU0027, 11LHU0027A, 11LHU0027C, 11LHU0027X, 11LHU0034, 11LHU0035, 11MHU0005, 11MHU0005A, 11MHU0005D, 1MHU0017, 11MM11935, 11MNG0008, 11MNG0008A, 11MNG0008B, 11MNG0009, 11MNG0009A, 11MNG0009C, 11MNG0018, 11MNG0018D, 11MNG0018E, 11MNG0025, 11MNG0025N, 11MNG0025P, 12AHU0001, 12AHU0001B, 12AHU0001C, 12AHU0014, 12BHU0010, 12BHU0010B, 12BHU0011, 12BHU0011A, 12BHU0025, 12BHU0025A, 12BHU0025B, 12BHU0025E, 12BHU0025G, 477420-14A

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

2.0 MM DRILL BIT, REF 71173501, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 09EHU0011, 09EHU0011A, 10AHU0015, 10AHU0015A, 10AHU0016, 10CHU0021, 10CHU0022, 10CHU0033, 10CHU0046, 10DHU0020, 10EHU0011, 10EHU0019, 10EHU0019X

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

2.0 MM X 191 MM DRILL, REF 71173802, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

All serial numbers shipped to customers; DFU 18-0062; Part No. B-MRA-L.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

22CM MICRO REVISION ATTACH, BLACK MAX

Lot #9013991X, 9014291X and 9014509X.

Ophthalmic Devices

1

No

Worldwide Distribution -- USA and Canada.

Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.

All serial numbers shipped to customers; DFU 18-0062; Part No. B-RED.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

26.65CM ATTACHMENT, BLACK MAX

Lot Numbers: 06DHU0001G, 08AHU0002H, 08AHU0002J, 08AHU0003F, 08EM20830A, 08EM21910A, 08FM01279A, 08FM03803A, 08GM02010A, 08HM00329A, 08HM00329B, 08HM03878A, 08HM08067A, 08KM00141A, 08KM21721A, 08KNG0009B, 08KNG0010B, 08LNG0007A, 08LNG0007B, 08LNG0007C, 08MM15654A, 08MNG0009A, 08MNG0009B, 08MNG0010, 08MNG0010A, 08MNG0011, 08MNG0011A, 09ANG0009, 09ANG0009A, 09ANG0013, 09ANG0013A, 09ANG0013B, 09ANG0014, 09ANG0017, 09ANG0018, 09ANG0018A, 09CM05224, 09CM06262, 09CM07601, 09CM07601A, 09CM08322, 09CM09267, 09CM10095, 09CNG0009A, 09CNG0009B, 09CNG0011, 09CNG0011A, 09CNG0011B, 09CNG0012, 09DNG0001, 09DNG0002A, 09DNG0002B, 09DNG0008, 09DNG0016A, 09DNG0017, 09DNG0018B, 09DNG0018C, 09DNG0019A, 09DNG0021, 09DNG0021B, 09DNG0023D, 09DNG0023E, 09DNG0023F, 09DNG0024, 09DNG0024A, 09DNG0024B, 09FM15589, 09FM15591, 09FM20533, 09FM20534, 09FM20535, 09FNG0006, 09FNG0006A, 09FNG0007, 09FNG0007A, 09FNG0007B, 09FNG0008, 09FNG0008A, 09FNG0008B, 09FNG0008C, 09FNG0011, 09FNG0011A, 09FNG0011B, 09FNG0015, 09FNG0015A, 09FNG0016, 09FNG0016A, 09FNG0017, 09FNG0017A, 09FNG0017B, 09FNG0018, 09FNG0018A, 09FNG0019, 09FNG0019A, 09GNG0014, 09GNG0014A, 09GNG0019, 09GNG0019A, 09GNG0020, 09GNG0020A, 09GNG0021, 09GNG0021A, 09JNG0001, 09JNG0001A, 09JNG0009, 09JNG0009A, 09JNG0011, 09JNG0011A, 09JNG0012, 09JNG0012A, 09JNG0013, 09JNG0013A, 09KM00535, 09KM03546, 09KM04458, 09KM04459, 09KM07958, 09KM07960, 09KM07963, 09MM00182, 09MM00185, 09MM00189, 09MM00196, 09MM08523, 09MM08526, 09MM08527, 09MM08530, 09MM09620, 09MM09622, 09MM09677, 10CM09863, 10CM11010, 10CM11014, 10CM11016, 10CM11017, 10CM11019, 10CM16244, 10CM16246, 10CM16248, 10CM16250, 10HNG0003, 10HNG0006, 10JNG0001, 10JNG0001A, 10JNG0002, 10JNG0002A, 10JNG0003, 10JNG0003A, 10JNG0004, 10JNG0004A, 10KM16333, 10KM16338, 10KM16343, 10KM16349, 10KM16352, 10KM16354, 10KNG0001, 10KNG0001A, 10KNG0002, 10KNG0002A, 10KNG0003, 10KNG0003A, 10KNG0005, 10KNG0005A, 10KNG0005B, 10KNG0006, 10KNG0006A, 10KNG0006B, 10KNG0009, 10KNG0009A, 10LM03223, 10LM03225, 10LM14475, 10LM14479, 10LM14480, 10LNG0014, 10LNG0014A, 10LNG0015, 10LNG0015A, 10LNG0016, 10LNG0016B, 10LNG0017, 10LNG0017A, 10MNG0003, 10MNG0003A, 10MNG0004, 10MNG0004A, 11ANG0001, 11ANG0001A, 11ANG0002, 11ANG0002A, 11ANG0003, 11ANG0003A, 11ANG0003B, 11ANG0009, 11ANG0009A, 11ANG0009B, 11BNG0001, 11BNG0001A, 11BNG0001B, 11BNG0002, 11BNG0002A, 11BNG0002B, 11CNG0001, 11CNG0001A, 11CNG0002, 11CNG0002A, 11CNG0003, 11CNG0003A, 11CNG0004, 11CNG0004A, 11DNG0004, 11DNG0004A, 11DNG0005, 11DNG0005A, 11DNG0006, 11DNG0006A, 11FM08241, 11FM08248, 11FM08249, 11FM08251, 11FM08253, 11FM11401, 11FM11402, 11FM11404, 11FM11405, 11FM11406, 11FM11408, 11FM14237, 11FM14238, 11FM14239, 11FM14240, 11FM14241, 11JM08775, 11JM08776, 11JM08777, 11JM08778, 11JM08779, 11JM08780, 11JM08784, 11JM14603, 11JM14605, 11JM14606, 11JM14607, 11JM16544, 11JM16549, 11JM16551, 11JM16561, 11KM04267, 11KM04269, 11KM04271, 11LM05280, 11LM05284, 11LM05286, 11LM05290, 11LM05295, 11LM05300, 11LM05359, 11LM06178, 11LM06184, 11LM06185, 11LM06194, 11LM09277, 11LM09278, 11LM09280, 11MM05190, 11MM05191, 11MM05193, 11MM05198, 11MM06015, 11MM06782, 11MM06809, 11MM08155, 11MM08157, 11MM08158, 11MNG0001, 11MNG0013, 11MNG0028, 11MNG0032, 12AM05781, 12AM05782, 12AM05783, 12AM05785, 12AM07665, 12AM07667, 12AM07668, 12AM07670, 12AM07671, 12AM07672, 12AM10996, 12AM12030, 12AM13198, 12AM13199, 12AM13200, 12ANG0008, 12BNG0007, 12BNG0007A, 12BNG0008, 12BNG0008A, 4500047794, 4500050285, 477751-32A, 477751BJ, 477808-11A, 477808-2A, 477808-4B, 477808-51B, 477808-53A, 477808-7A, 477808E, 477808J, 480313-15A, 480313-50A, 480313-7A

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

2.7 MM DRILL BIT, REF 71173503, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 09EHU0019, 09EHU0019A, 10BHU0011, 10BHU0012, 10BHU0013, 10BHU0014, 10BHU0017, 10CHU0009, 10CHU0028, 10EHU0012, 10EHU0012A, 10EHU0017, 10EHU0018, 10FHU0014, 10JHU0010

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

2.7 MM X 191 MM DRILL, REF 71173804, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

SIN 2017070001 SIN 2017070008 SIN 2017070002 SIN 2017070009 SIN 2017070003 SIN 2017070010 SIN 2017070004 SIN 2017070011 SIN 2017070005 SIN 2017070012 SIN 2017070006 SIN 2017070013 SIN 2017070007

Obstetrical and Gynecological Devices

2

No

Worldwide Distribution - US Nationwide and the countries of ( Canada and England)

Cooper Surgical 2 MHZ Waterproof OB Probe || Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.

Lot Numbers: 06GM12595B, 08CM06783A, 09CM18034, 09CM18034A, 09EM01140, 09EM01141A,  09EM19903, 09EM19906, 09EM19907, 09EM19910A, 09EM19963, 09EM19975, 09GM01874, 09GM01874A, 09GM10893, 09GM10894, 09HM04043, 09HM04044, 09JM13526, 09JM13529, 09JM15025, 09JM15026, 09KM15318, 09KM15320, 09KM15323, 09KM15329, 09KM15807, 09KM15807A, 10DM06041, 10DM06042, 10DM06161, 10DM06162, 10DM06163, 10DM06165, 10DM14300, 10DM14304, 10DM14307, 10DM14310, 10GM08573, 10GM08577, 10GM13126, 10JM11193, 10JM11195, 10JM11197, 10JM11199, 10KM06443, 10KM06448, 10KM06451, 11AM06081, 11AM06082, 11AM06083, 11AM06084, 11AM06087, 11BM10394, 11BM10395, 11BM10396, 11CM08517, 11CM08521, 11CM08530, 11CM08567, 11CM08573, 11DM07718, 11DM07722, 11EM07419, 11EM07421, 11EM07727, 11EM07732, 11GM06594, 11GM06595, 11GM06596, 11GM06711, 11HM15597, 11HM15606, 11HM15611, 11HM15614, 11HM15623, 11JM09277, 11JM09278, 11JM09283, 11KM07809, 11KM07810, 11KM07811, 11KM07812, 11KM07813, 11LM09301, 11LM09302, 11LM10337, 11LM10339, 12BM09921, 12BM09923, 12BM09926, 12BM09929, 12BM09932, 12BM13643, 478052-30A

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

3.2 MM LONG GRADUATED BRAD POINT DRILL, REF 71751149, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Number 1424970-A

General and Plastic Surgery Devices

2

No

Nationwide Distribution including Texas

3.0 60 Degree wand Part Number A2530-01 is an ablation wand || Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels.

309603 Syringe 5ML LL Syringe only 5067050; 309603 Syringe 5ML LL Syringe only 5062940

General Hospital and Personal Use Devices

2

No

BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.

# 309603 -- Syringe 5Ml LL syringe.

309604 10 ML Syringe 5074833

General Hospital and Personal Use Devices

2

No

BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.

#309604 -- 10 mL syringe

309604 Syringe 10 ML LL 5063484; 309604 Syringe 10 ML LL 5063495; 309604 Syringe 10 ML LL 5055564; 309604 Syringe 10 ML LL 5055567; 309604 Syringe 10 ML LL 5063493.

General Hospital and Personal Use Devices

2

No

BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.

# 309604 -- Syringe 10 mL LL

309644 10 ml Syringe with 20 G1'' Needle 5033890

General Hospital and Personal Use Devices

2

No

BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.

#309644 -- 10 ml syringe with 20 G1'' Needle

309661 Syringe only LL 20 ML 5061527; 309661 Syringe only LL 20 ML 5047172

General Hospital and Personal Use Devices

2

No

BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.

#309661 -- Syringe only ll 20 mL

Lot Number Q833660-A

General and Plastic Surgery Devices

2

No

Nationwide Distribution including Texas

3.0mm 45 Degree Beval with cable Product Number AC2430-01 is an ablation wand

Lot Number 1324341-2

General and Plastic Surgery Devices

2

No

Nationwide Distribution including Texas

3.0mm 45 Degree bevel Part Number A2430-01 is an ablation wand || Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

The following Serial Numbers of this device were subject to recall: 101, 102, 201, 202, 203, 204, 205, 206, 207, 309, 310.

Radiology Devices

2

No

Worldwide, including USA, (states of CA, NJ, PA, MN, IA, MA, WI, WA, and FL) Switzerland, the United Kingdom, France, Canada and Finland.

3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System.

Lot Numbers: 06HHU0020E, 07HM04821A, 07JHU0008, 08AM10972A, 08KM16567A, 09FM00898,  09FM00899, 09FM00900, 09FM00901, 09FM00902, 09FM00903, 09FM03558, 10AM01791, 10AM01796, 10AM01799, 10AM01803, 10BM04399, 10CM18678, 10CM18680, 10CM18682, 10HM07692, 10HM07789, 10JM07318, 10JM07320, 11AM15222, 11BM09186, 11BM09205, 11DM02807, 11DM02828, 11FM04982, 11FM04985, 11HM18980, 11HM18991, 11KM09348, 11KM09350, 11KM15076, 11KM15077, 12BM08098, 475163-13A, 475163-30B, 475843-15B, 475843-19A, 475843-1B, 475843C, 483936-1B, 485275-4B

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

3.2 MM IMHS(R) CP SHORT BRAD POINT DRILL, REF 71687001, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 06JM08741B, 07GM04922B, 09CM18043, 09HM04046A, 09JM15028, 09JM15029, 09KM15327, 10DM14293, 10DM14294, 10DM14295, 10DM14296, 10DM14297, 10DM14298, 10KM06473, 11AM08963, 11AM08964, 11CM08579, 11CM08581, 11HM15636, 11JM09284, 11KM07815, 11KM07817, 11LM09303, 11LM10342, 11LM10344, 12BM11721

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

3.2 MM LONG GRADUATED BRAD POINT DRILL, REF 71780105, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 09FM13048, 09FM13050, 09HM19220, 09JM05321, 09JM05323A, 10CM17257,  10CM17264, 10CM17267, 10DM13250, 10EM07916, 10FM17121, 10FM19218, 10JM02801, 10JM02804, 10KM03818, 10KM03819, 11AM05484, 11AM15993, 11CM10621, 11EM08614, 11EM08616, 11FM16054, 11KM06137, 11LM04640, 11MM09298

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

3.2 MM TROCAR, REF 71751136, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers 0933831-2, 093534102, and 5L14150-A

General and Plastic Surgery Devices

2

No

Nationwide Distribution including Texas

3.5mm 90 Degree Part Number A1335-01 is an ablation wand || Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.