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  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
DR. DESAI''S PACK
  • Modelo / Serial
    Catalog number CPA-3064 Lot numbers 000005461, 000005613, 000005829, 000005854, 000006093, 000006210, 000006226, 000006427
  • Distribución
    The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
  • Descripción del producto
    DR. DESAI''S PACK
  • Manufacturer
    Windstone Medical, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de DR. DESAI''S PACK
PENROSE ACE BANDAGE
  • Modelo / Serial
    Catalog Number CPA-3294 Lot Numbers 000000819, 000000820, 00001431, 000001432, 000002405, 000002533, 000002755, 000003124, 000003125, 000004077, 000004189, 000004657, 000004658, 000005472, 000005979
  • Distribución
    The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
  • Descripción del producto
    PENROSE ACE BANDAGE
  • Manufacturer
    Windstone Medical, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de PENROSE ACE BANDAGE
Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised || 3mm x 17cm || Reference Number: 100/111...
  • Modelo / Serial
    Lot Number: 161633
  • Distribución
    Nationwide
  • Descripción del producto
    Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised || 3mm x 17cm || Reference Number: 100/111/030
  • Manufacturer
    Portex Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised || 3mm x 17cm || Reference Number: 100/111/030
Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised || 3.5mm x 19cm || Reference Number: 100/1...
  • Modelo / Serial
    Lot Number: 161638
  • Distribución
    Nationwide
  • Descripción del producto
    Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised || 3.5mm x 19cm || Reference Number: 100/111/035
  • Manufacturer
    Portex Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised || 3.5mm x 19cm || Reference Number: 100/111/035
Device Recall Boston Scientific /Micorvasive
  • Modelo / Serial
    4097154 4126946 4145035 4158456 4193792 4212753 4221510 4231545 4256164 4262043 4258584 4282986 4313907 4323261 4349628 4375687 4392520 4405118 4408527 4414677 4425997 4464404 4464403 4468969 4494611 4528589 4537936 4550692 4557360 4562655 4579693 4583642 4625634 4628069 4639625 4652811 4689625 4701139 4701138 4727026 4742360 4764119 4764122 4774555   4788365 4823397 4830419 4845754 4900789 4910488 4915451 4935096 4963935 4963936 4983393 4992627 5007857 5019451 5022419 5038639 5065152 5121437 5129514 5140440 5155296 5158742 5169243 5173373 5182914 5186852 5205601 5223778 5227258 5238638 5246424 5251510 5269078 5288531 5301576 5320588 5371233 5427428 5440613 5473223 5501877 5505775 5511863 5547602
  • Distribución
    Nationwide
  • Descripción del producto
    ASAP Channel Cut Biopsy System, 15 gauge || Reference Number: 1390
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Boston Scientific /Micorvasive
Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. || Kit: AMPLICOR M. avium...
  • Modelo / Serial
    Amplicor [3] AV-HRP, Lot No. E09569 found in kit lot:  Lot E12990, Material No. 20759880018, Exp. 11/2004.
  • Distribución
    ♦ Amplicor CT/NG CT Detection Kit, Lot No.E12231, Material No.20759392018, Expiration 2/2005 , Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. ♦ Amplicor CT/NG NG Detection Kit, Lot No.E12647, Material No.20759406018, Expiration 2/2005, Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. ♦ Amplicor HCV Detection Kit, v2.0, Lot No.F01023, Material No.21118439018, Expiration 5/2005, Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. ♦ Amplicor IC Detection Kit, 96 tests, Lot No.E09554, Material No.20751952018, Expiration 5/2005, Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. Export-U.S Distributed Products: AmpliCap HCV Monitor Test, Lot No.E09193, Material No.21111337018, Expiration 8/2004 , Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan. Amplicor IC Detection Kit, Lot No.E13115, Material No.20763306122, Expiration 7/2005, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan; Shipped To: Roche Diagnostics Canada, 201 Boulevard Armand-Frappier, Laval QC H7V 4A2, Canada; Shipped To: Roche Diagnostics GmbH, GX-OSW, Sandhoferstr. 116, D-68305 Mannheim. Amplicor M. avium Detection Kit, Lot No.E12990, Material No.20759880018, Expiration 11/2004, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan. Amplicor MTB Detection Kit, Lot No.E13307, Material No.20757462122, Expiration 9/2004, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan; Shipped To: Roche Diagnostics Canada, 201 Boulevard Armand-Frappier, Laval QC H7V 4A2, Canada Shipped To: Roche Diagnostics GmbH, GX-OSW, Sandhoferstr. 116, D-68305 Mannheim. Amplicor NG Detection Kit, Lot No.E10894, Material No.20744026122, Expiration 2/2005, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan ; Shipped To: Roche Diagnostics Canada, 201 Boulevard Armand-Frappier, Laval QC H7V 4A2, Canada; Shipped To: Roche Diagnostics GmbH, GX-OSW, Sandhoferstr. 116, D-68305 Mannheim. There are no Govt. accounts.
  • Descripción del producto
    Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. || Kit: AMPLICOR M. avium Detection Kit, Export,RUO.
  • Manufacturer
    Roche Molecular Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. || Kit: AMPLICOR M. avium Detection Kit, Export,RUO.
Device Recall AMPLATZER Delivery Systems
  • Modelo / Serial
    M01K01-6, M02C12-24, M02C25-15, M02F05-23, M02F24-05, M02L02-21, M03A09-10, M03A09-15, M03A20-10, M03B20-17 M03C24-14, M03F02-17, M03G23-08, M03H12-42, M03J19-07 M03K14-06, M03K28-35, M03L11-48, M04B03-09, M04B03-14 M04C08-12, M04D06-12, M04E11-28, M04E24-20, M04F08-23 M04H03-23, M04J17-07, M04K07-02
  • Distribución
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Descripción del producto
    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/80. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
    AGA Medical Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall AMPLATZER Delivery Systems
Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche...
  • Modelo / Serial
    All units. (Sold only outside of the U.S. by Vital in Netherlands).
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.
  • Descripción del producto
    Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche part number 03522032001.
  • Manufacturer
    Roche Diagnostics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche part number 03522032001.
Device Recall Active Life
  • Modelo / Serial
    Lot #5H0436N.  UPC Code: 30003-022766
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Distribución
    Nationwide
  • Descripción del producto
    Active Life Non-Convex Drainable Stomahesive pouch-1 1/4' (32 mm) Product No: 022766 Manf. by ConvaTec, Skillman, NJ.
  • Manufacturer
    ConvaTec
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Active Life
GSK
  • Modelo / Serial
    Shipper case lot #8008580, Retal Carton Lot #4543U8008580
  • Distribución
    US Nationwide
  • Descripción del producto
    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
  • Manufacturer
    GSK Consumer Healthcare
  • 1 Event
    • Retiro De Equipo (Recall) de GSK
VITEK 2 AST N235
  • Modelo / Serial
    6350208203 22/Jun/18
  • Distribución
    Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
  • Descripción del producto
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N235), REF 413170, 20 cards per carton.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de VITEK 2 AST N235
Device Recall The Elekta Synergy System
  • Modelo / Serial
    151855, 151340, 151587, 152246, 151694, 105864, 105932, 105559, 151574, 152397, 151803, 151875, 151521, 151965, 151504, 151159, 105941, 151418, 151538, 105555, 151728, 151729, 151399, 105809, 151802, 151421, 105723, 105803, 151362, 151545, 151628, 151566, 152271, 151736, 151700, 151866, 151698, 151699, 151517, 151539, 151636, 151695, 151696, 151981, 105837, 151811, 105584, 151568, 151390, 151258, 151360, 151328, 105590, 151167, 151584, 151317, 151522, 105925, 151055, 151808, 151367, 151769, 151969, 151801, 151977, 105894, 151033, 151391, 151708, 152043, 151267, 151809, 152205, 152019, 151507, 105883, 105914, 151238, 151640, 152163, 151623, 151627, 151443, 151479, 152200, 152192, 151933, 152126, 152115, 152116, 151422, 152123, 151954, 105992, 105950, 151955, 152365, 151014, 151722, 151724, 151779, 151051, 151632, 105644, 152091, 105960, 151810, 151467, 151678, 151514, 151791, 152176, 152064, 151962, 151848, 151849, 151173, 151216, 151430, 151931, 105567, 105744, 105984, 151412, 151616, 151867, 151141, 151228, 152177, 151433, 151611, 152008, 105728, 151151, 105561, 151714, 105646, 152023, 105773, 105587, 105890, 151653, 151785, 151892, 152223, 152352, 152353, 152359, 152362, 151763, 151076, 151515, 105828, 151704, 151765, 151325, 151861, 151035, 151059, 105630, 151675, 105591, 105929, 151024, 151860, 152051, 152031, 105868, 105949, 151260, 151709, 151029, 105770, 105776, 105846, 105895, 151886, 151956, 151812, 151523, 105568, 105936, 105806, 151519, 152175, 152232, 152257, 151952, 151689, 151410, 151084, 105593, 151305, 151371, 105969, 151016, 151774, 152217, 152220, 151435, 105926, 151734, 105872, 151530, 105636, 151626, 151842, 151942, 151432, 151783, 151567, 151598, 151601, 151989, 151958, 151959, 151960, 151821, 151820, 105676, 151319, 151557, 151558, 151411, 151423, 105829, 105844, 151380, 151770, 151864, 105666, 151760, 105902, 105998, 105637, 151073, 151253, 151269, 151396, 151104, 105678, 105879, 105727, 105731, 105782, 105841, 151093, 151110, 151363, 151369, 151705, 152154, 151782, 151098, 151099, 151789, 105649, 151309, 152103, 152301, 151847, 105754, 105982, 151160, 151634, 151684, 151793, 151388, 151394, 105859, 151387, 151978, 152210, 152211, 151080, 152248, 151398, 152222, 151540, 151015, 152214, 151446, 105580, 151143, 152158, 151301, 152392, 105647, 105699, 105898, 151441, 105660, 151038, 151229, 105564, 105565, 152364, 105886, 151256, 151154, 151168, 151178, 151839, 151537, 151155, 151156, 151157, 151491, 105910, 152117, 105853, 105854, 105856, 151759, 151053, 151359, 105624, 151710, 152079, 152080, 105563, 105648, 105655, 151585, 105882, 151326, 151327, 151130, 151250, 151828, 151881, 151882, 105796, 105812, 151245, 152307, 152308, 152331, 105612, 151416, 151805, 152098, 151579, 151961, 105586, 151683, 151764, 105621, 151664, 151953, 105990, 151674, 105657, 101751, 152036, 151885, 105610, 151134, 151266, 151672, 151074, 151008, 151595, 152174, 151259, 151352, 152207, 151298
  • Clasificación del producto
    Radiology Devices
  • Distribución
    Nationwide and Puerto Rico
  • Descripción del producto
    Elekta Synergy || The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • Manufacturer
    Elekta, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall The Elekta Synergy System
Device Recall ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Scre...
  • Modelo / Serial
    **All lots.
  • Distribución
    Worldwide Distribution: Nationwide distribution including the states of MN, OK, IL, AK, CA, PA, UT, LA, SC, NY, MI, GA, WI, KY, AL, MO, AZ, TN, TX, MA, NE, OH, FL, CO, MT, CT, VA, NC, NH, WA, WV, WY, IN, IA, KS, MT, ME, DE, DC, NJ, MD, MS, NV, HI, ID, ND, and AR; and the country of Uruguay.
  • Descripción del producto
    ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (976-516). || Medtronic Sofamor Danek USA, Inc. || This instrument is a precision device which incorporates a measuring function.
  • Manufacturer
    Medtronic Sofamor Danek USA Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy
Device Recall MDMA/Ecstasy Test Card
  • Modelo / Serial
    Catalog number: 74024, All lots
  • Distribución
    Distributed in the states of CA, FL, NJ, TX, and NY.
  • Descripción del producto
    MDMA/Ecstasy Test Card; || LumiQuick. || Santa Clara, CA 95054
  • Manufacturer
    LumiQuick Diagnostics Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MDMA/Ecstasy Test Card
Device Recall Methadone Test Strip
  • Modelo / Serial
    Catalog number: 74025, All lots
  • Distribución
    Distributed in the states of CA, FL, NJ, TX, and NY.
  • Descripción del producto
    Methadone Test Strip; || LumiQuick,. || Santa Clara, CA 95054
  • Manufacturer
    LumiQuick Diagnostics Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Methadone Test Strip
Device Recall Morphine Strip (300
  • Modelo / Serial
    Catalog number: 74029, All lots
  • Distribución
    Distributed in the states of CA, FL, NJ, TX, and NY.
  • Descripción del producto
    Morphine Strip (300); || LumiQuick, || Santa Clara, CA 95054
  • Manufacturer
    LumiQuick Diagnostics Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Morphine Strip (300
Device Recall Myoglobin Test Card (Serum)
  • Modelo / Serial
    Catalog number: 75005, All lots
  • Distribución
    Distributed in the states of CA, FL, NJ, TX, and NY.
  • Descripción del producto
    Myoglobin Test Card (Serum); || LumiQuick,. || Santa Clara, CA 95054
  • Manufacturer
    LumiQuick Diagnostics Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Myoglobin Test Card (Serum)
Device Recall Siemens CentraLink Data Management System
  • Modelo / Serial
    Catalog Numbers: 10810210, 10811596, 10814296, 10814298, 10814877, 10815474
  • Distribución
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Lebanon, Lithuania, Luxemburg, Malaysia, Mexico, Netherland, New Zealand Norway, Pakistan, Portugal, Peru, Qatar, Russia, Saudi Arabia, Singapore Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand United Arab Emirates, United Kingdom, Uruguay, Zambia.
  • Descripción del producto
    Siemens CentraLink Data Management System, software version 14. || The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Siemens CentraLink Data Management System
Device Recall Laser Distance and Level Transmitters
  • Modelo / Serial
    Model No. LT4C
  • Distribución
    Nationwide
  • Descripción del producto
    Laser Distance and Level Transmitters, Model No. LT4C, ASI, 8570 Katy Freeway, Suite 117, Houston, TX 77024
  • Manufacturer
    K Tek
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Laser Distance and Level Transmitters
Device Recall Laser Distance and Level Transmitters
  • Modelo / Serial
    Model No. LM4C
  • Distribución
    Nationwide
  • Descripción del producto
    Laser Level Transmitters, Model No. LM4C, K-TEK, 18321 Swamp Road, Prairieville, LA 70769
  • Manufacturer
    K Tek
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Laser Distance and Level Transmitters
Device Recall Matrix MAX 3
  • Modelo / Serial
    Serial number 3337328
  • Distribución
    Worldwide Distribution-USA and Canada
  • Descripción del producto
    Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, SKF USA, Inc. Norristown, PA 19403
  • Manufacturer
    Skf USA Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Matrix MAX 3
Device Recall Epic DR Model V239
  • Modelo / Serial
    all serial numbers
  • Distribución
    Nationwide and Internationally: Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Malaysia,Mexico, Netherlands, New Zealand, Norway, Peru. Poland, Portugal, Republic of Panama, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, United Kingdom, Uruguay and Venezuela.
  • Descripción del producto
    Implantable Cardioverter Defibrillator || EPIC + DR Tiered-therapy cardioverter/defibrillator, Model V-239
  • Manufacturer
    St Jude Medical CRMD
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Epic DR Model V239
Device Recall Hall EasyFit Prosthetic Heart Valve A
  • Modelo / Serial
    USA 19A554013J 19A554110J 19A554192J 19A554193J 19A554196J 19A554287J 19A554292J 19A554298J 21A553685J 21A553921J 21A553982J 21A553985J 21A554133J 21A554959J 21A555003J 21A555206J 21A555473J 21A555711J 21A555821J 21A555906J 21A555914J 23A553480J 23A553533J 23A553611J 23A553837J 23A553987J 23A554034J 23A554663J 23A555403J 23A555772J 23A556211J 23A556271J 25A554669J 25A555417J 25A556058J 25A556107J 27A549092J 27A549340J 27A553554J 27A554155J 27A554159J 27A554224J 27A554225J 27A554232J 27A554236J 27A554436J 27A554507J 27A555286J 27A555289J 27A556046J 27A559810J 27A559811J 27A559812J 27A559918J 29A549102J 29A549192J 29A549193J 29A549242J 29A551836J 29A551988J 29A554151J 29A554156J 29A554158J 29A554226J 29A554231J 29A554435J 29A554438J 29A554439J, and 29A554440J  EUROPE 19A554058J 19A554109J 19A554126J 19A554201J 19A554289J 19A554290J 19A554604J 19A554654J 19A554749J 19A554754J 19A560318J 19A560981J 19A560992J 19A561161J 19A561162J 19A561172J 19A561230J 19A561233J 19A561237J 19A561246J 21A553907J 21A554016J 21A555382J 21A555395J 21A555637J 21A555719J 21A555723J 23A553121J 23A553122J 23A553200J 23A553412J 23A553478J 23A553531J 23A553539J 23A553605J 23A553616J 23A553838J 23A554137J 23A554331J 23A554493J 23A554658J 23A554709J 23A554716J 23A554720J 23A554843J 23A554965J 23A554968J 23A555025J 23A555251J 23A555263J 23A555516J 23A555519J 23A555523J 23A555524J 23A555527J 23A555531J 23A555532J 23A555613J 23A555622J 23A555623J 23A555675J 23A555681J 23A555735J 23A555773J 23A555775J 23A555915J 23A555917J 23A555922J 23A555924J 23A555926J 23A555927J 23A555928J 23A555929J 23A556008J 23A556011J 25A554042J 25A554044J 25A554047J 25A554139J 25A554144J 25A554217J 25A554220J 25A554221J 25A554425J 25A554426J 25A554428J 25A554429J 25A554431J 25A554432J 25A554503J 25A554554J 25A554556J 25A554557J 25A554558J 25A554561J 25A554562J 25A556030J 25A556035J 25A556038J 25A556101J 25A556116J 27A549104J 27A549189J 27A549194J 27A549245J 27A549339J 27A549341J 27A551835J 27A551989J 27A553552J 27A553553J 27A554157J 27A554223J 27A554230J 27A554237J 27A554976J 27A555291J, and  CANADA 21A554071J 23A555518J 25A554143J 27A551991J, and 27A555283J   OTHER 19A553455J 19A553748J 19A553881J 19A553901J 19A553998J 19A554000J 19A554001J 19A554010J 19A554059J 19A554063J 19A554064J 19A554108J 19A554113J 19A554122J 19A554194J 19A554202J 21A553173J 21A553181J 21A553405J 21A553466J 21A553525J 21A553598J 21A553687J 21A553790J 21A553825J 21A553828J 21A553832J 21A553905J 21A553910J 21A553913J 21A553920J 21A553977J 21A553981J 21A553983J 21A553984J 21A554089J 21A554131J 21A554308J 21A554309J 21A554311J 21A554312J 21A554313J 21A554314J 21A554320J 21A554607J 21A554702J 21A554703J 21A554706J 21A554758J 21A554793J 21A554794J 21A554797J 21A554800J 21A554837J 21A554839J 21A554840J 21A554841J 21A554887J 21A554889J 21A554893J 21A554895J 21A554896J 21A554899J 21A554954J 21A554962J 21A555002J 21A555004J 21A555005J 21A555006J 21A555007J 21A555014J 21A555203J 21A555205J 21A555375J 21A555378J 21A555385J 21A555386J 21A555388J 21A555397J 21A555477J 21A555478J 21A555483J 21A555494J 21A555496J 21A555499J 21A555500J 21A555504J 21A555507J 21A555580J 21A555581J 21A555583J 21A555584J 21A555626J 21A555627J 21A555630J 21A555633J 21A555634J 21A555673J 21A555674J 21A555706J 21A555708J 21A555709J 21A555716J 21A555717J 21A555726J 21A555806J 21A555909J 21A555913J 21A555992J 21A555993J 21A555994J 21A555995J 21A555997J 21A556053J 21A556085J 21A556151J 23A553484J 23A554024J 23A554027J 23A554028J 23A554031J 23A554136J 23A554206J 23A554208J 23A554213J 23A554329J 23A554334J 23A554339J 23A554340J 23A554344J 23A554383J 23A554384J 23A554386J 23A554488J 23A554489J 23A554612J 23A554657J 23A554661J 23A554664J 23A554711J 23A554717J 23A555027J 23A555529J 23A555680J 23A555732J 23A555738J 23A555916J 23A555918J 23A555923J 23A555925J 23A556005J 23A556006J 23A556009J 23A556013J 23A556015J 23A556019J 23A556021J 23A556023J 23A556024J 23A556096J 23A556206J 23A556208J 23A556210J 25A554563J 25A554666J 25A555279J 25A555280J 25A555282J 25A555419J 25A555428J 25A555826J 25A555939J 25A555940J 25A556039J 25A556112J 27A549240J 27A554506J 27A554977J, and 29A554434J
  • Distribución
    Class II Recall - Worldwide Distribution --- including USA states of TX, WY, CA, MI, WI, MO, IL, NY, TN, AR, LA, KY, WA, WV, and countries of Canada, Hong Kong, Australia, Albania, Belgium, Croatia, Germany, India, Italy, Netherlands, Poland, Romania, Russian Federation, South Africa, and Turkey.
  • Descripción del producto
    Hall Easy-Fit¿ Prosthetic Heart Valve - Aortic A7700. The device uses a single pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is machined into final configuration from a single piece of solid titanium and has no welds or introduced bends. It is an open-membered design in which all members project centrally without distal attachment. A rotatable fabric sewing ring is affixed to the valve. The valve is provided on a holder (collect) to facilitate insertion and to provide protection during shipping and handling. The valve is sterile and non-pyrogenic if seal and package are not opened, damaged, or broken.
  • Manufacturer
    Medtronic Heart Valve Division
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Hall EasyFit Prosthetic Heart Valve A
Device Recall Fresenius 2008T Hemodialysis Machine
  • Modelo / Serial
    Units distributed between Sept 1, 2010 and January 5, 2011. Serial Numbers: 0T0S100031 0T0S100035 0T0S100036 0T0S100037 0T0S100039 0T0S100040 0T0S100041 0T0S100042 0T0S100046 0T0S100048 0T0S100050 0T0S100052 0T0S100058 0T0S100059 0T0S100060 0T0S100061 0T0S100062 0T0S100063 0T0S100064 0T0S100065 0T0S100067 0T0S100068 0T0S100070 0T0S100071 0T0S100072 0T0S100080 0T0S100084 0T0S100085 0T0S100086 0T0S100087 0T0S100088 0T0S100089 0T0S100090 0T0S100093 0T0S100094 0T0S100095 0T0S100096 0T0S100097 0T0S100098 0T0S100099 0T0S100100 0T0S100101 0T0S100102 0T0S100103 0T0S100105 0T0S100107 0T0S100109 0T0S100110 0T0S100111 0T0S100113 0T0S100114 0T0S100115 0T0S100116 0T0S100117 0T0S100118 0T0S100119 0T0S100121 0T0S100122 0T0S100123 0T0S100124 0T0S100125 0T0S100126 0T0S100127 0T0S100129 0T0S100130 0T0S100131 0T0S100132 0T0S100133 0T0S100135 0T0S100136 0T0S100137 0T0S100138 0T0S100139 0T0S100140 0T0S100141 0T0S100142 0T0S100143 0T0S100144 0T0S100145 0T0S100146 0T0S100147 0T0S100148 0T0S100149 0T0S100150 0T0S100151 0T0S100152 0T0S100153 0T0S100154 0T0S100155 0T0S100156 0T0S100157 0T0S100158 0T0S100159 0T0S100160 0T0S100161 0T0S100162 0T0S100163 0T0S100164 0T0S100165 0T0S100166 0T0S100167 0T0S100168 0T0S100170 0T0S100171 0T0S100172 0T0S100173 0T0S100174 0T0S100175 0T0S100176 0T0S100177 0T0S100179 0T0S100180 0T0S100181 0T0S100182 0T0S100183 0T0S100184 0T0S100185 0T0S100186 0T0S100187 0T0S100188 0T0S100189 0T0S100190 0T0S100191 0T0S100192 0T0S100193 0T0S100194 0T0S100195 0T0S100196 0T0S100197 0T0S100198 0T0S100199 0T0S100200 0T0S100202 0T0S100203 0T0S100204 0T0S100205 0T0S100206 0T0S100207 0T0S100208 0T0S100210 0T0S100211 0T0S100212 0T0S100213 0T0S100214 0T0S100215 0T0S100216 0T0S100217 0T0S100218 0T0S100220 0T0S100221 0T0S100222 0T0S100223 0T0S100224 0T0S100225 0T0S100226 0T0S100227 0T0S100228 0T0S100229 0T0S100230 0T0S100231 0T0S100232 0T0S100233 0T0S100234 0T0S100235 0T0S100236 0T0S100237 0T0S100238 0T0S100239 0T0S100240 0T0S100241 0T0S100242 0T0S100243 0T0S100244 0T0S100245 0T0S100246 0T0S100247 0T0S100248 0T0S100249 0T0S100250 0T0S100251 0T0S100252 0T0S100253 0T0S100254 0T0S100255 0T0S100256 0T0S100257 0T0S100258 0T0S100259 0T0S100260 0T0S100261 0T0S100262 0T0S100263 0T0S100264 0T0S100265 0T0S100266 0T0S100267 0T0S100268 0T0S100270 0T0S100271 0T0S100272 0T0S100274 0T0S100275 0T0S100276 0T0S100277 0T0S100280 0T0S100281 0T0S100282 0T0S100284 0T0S100285 0T0S100286 0T0S100288 0T0S100289 0T0S100291 0T0S100293 0T0S100294 0T0S100295 0T0S100296 0T0S100297 0T0S100298 0T0S100299 0T0S100300 0T0S100301 0T0S100302 0T0S100303 0T0S100304 0T0S100305 0T0S100306 0T0S100307 0T0S100308 0T0S100309 0T0S100310 0T0S100311 0T0S100312 0T0S100313 0T0S100314 0T0S100315 0T0S100316 0T0S100317 0T0S100318 0T0S100319 0T0S100320 0T0S100321 0T0S100322 0T0S100323 0T0S100324 0T0S100325 0T0S100326 0T0S100327 0T0S100328 0T0S100329 0T0S100330 0T0S100331 0T0S100332 0T0S100333 0T0S100334 0T0S100335 0T0S100336 0T0S100337 0T0S100338 0T0S100339 0T0S100340 0T0S100341 0T0S100342 0T0S100343 0T0S100344 0T0S100345 0T0S100346 0T0S100347 0T0S100348 0T0S100349 0T0S100350 0T0S100351 0T0S100352 0T0S100353 0T0S100354 0T0S100355 0T0S100356 0T0S100357 0T0S100358 0T0S100359 0T0S100360 0T0S100361 0T0S100362 0T0S100363 0T0S100364 0T0S100365 0T0S100366 0T0S100367 0T0S100368 0T0S100369 0T0S100370 0T0S100371 0T0S100372 0T0S100373 0T0S100374 0T0S100375 0T0S100376 0T0S100377 0T0S100378 0T0S100379 0T0S100380 0T0S100381 0T0S100382 0T0S100383 0T0S100384 0T0S100385 0T0S100386 0T0S100387 0T0S100388 0T0S100389 0T0S100390 0T0S100391 0T0S100392 0T0S100393 0T0S100394 0T0S100395 0T0S100396 0T0S100397 0T0S100398 0T0S100399 0T0S100400 0T0S100401 0T0S100402 0T0S100403 0T0S100404 0T0S100405 0T0S100406 0T0S100407 0T0S100408 0T0S100409 0T0S100410 0T0S100411 0T0S100412 0T0S100413 0T0S100414 0T0S100415 0T0S100416 0T0S100417 0T0S100418 0T0S100419 0T0S100420 0T0S100421 0T0S100422 0T0S100423 0T0S100424 0T0S100425 0T0S100426 0T0S100427 0T0S100428 0T0S100429 0T0S100430 0T0S100431 0T0S100432 0T0S100433 0T0S100434 0T0S100435 0T0S100436 0T0S100437 0T0S100438 0T0S100439 0T0S100440 0T0S100441 0T0S100442 0T0S100443 0T0S100444 0T0S100445 0T0S100446 0T0S100447 0T0S100448 0T0S100449 0T0S100450 0T0S100451 0T0S100452 0T0S100453 0T0S100454 0T0S100455 0T0S100456 0T0S100457 0T0S100458 0T0S100459 0T0S100460 0T0S100461 0T0S100462 0T0S100463 0T0S100464 0T0S100465 0T0S100466 0T0S100467 0T0S100468 0T0S100469 0T0S100470 0T0S100471 0T0S100472 0T0S100473 0T0S100474 0T0S100475 0T0S100477 0T0S100478 0T0S100479 0T0S100480 0T0S100481 0T0S100483 0T0S100484 0T0S100485 0T0S100486 0T0S100487 0T0S100488 0T0S100489 0T0S100490 0T0S100491 0T0S100492 0T0S100493 0T0S100494 0T0S100495 0T0S100496 0T0S100497 0T0S100498 0T0S100499 0T0S100500 0T0S100501 0T0S100502 0T0S100503 0T0S100504 0T0S100505 0T0S100506 0T0S100507 0T0S100508 0T0S100509 0T0S100510 0T0S100511 0T0S100512 0T0S100513 0T0S100514 0T0S100515 0T0S100516 0T0S100517 0T0S100518 0T0S100519 0T0S100520 0T0S100521 0T0S100522 0T0S100523 0T0S100524 0T0S100525 0T0S100526 0T0S100527 0T0S100528 0T0S100529 0T0S100530 0T0S100531 0T0S100532 0T0S100533 0T0S100534 0T0S1005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  • Distribución
    Worldwide Distribution - USA and Canada
  • Descripción del producto
    Fresenius 2008T Hemodialysis Machine || Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS || Part Number 190713, 2008T Hemodialysis System with CDX || Part Number 190766, 2008T Hemodialysis System with biBag || The Fresenius 2008T is indicated for acute and chronic dialysis therapy.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Fresenius 2008T Hemodialysis Machine
Xpert EV Assay, Catalog GXEV100N10.
  • Modelo / Serial
    batch 1000045409 (lot 06802)
  • Distribución
    USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay
  • Descripción del producto
    Xpert EV Assay, Catalog GXEV-100N-10. || The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individuals with signs and symptoms of meningitis.
  • Manufacturer
    Cepheid
  • 1 Event
    • Retiro De Equipo (Recall) de Xpert EV Assay, Catalog GXEV100N10.
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