Device Recall RENASYS

  • Modelo / Serial
    Item 66800912 Lot # M400071
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of FL, NC, CA, MO, MA, TX, NY, OH, CO, VA, IL, NJ, TN, NV, MN including Puerto Rico and countries of Canada, Mexico, Dubai, Argentina, Australia, Colombia, Germany, Hong Kong, Jordon, Malaysia, Thailand, Tunisia, New Zealand, South Africa, Shanghai, Brazil, Saudi Arabia and Lebanon.
  • Descripción del producto
    RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier || Product Usage: || RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Smith & Nephew, Inc., 970 Lake Carillon Dr, Ste 110, Saint Petersburg FL 33716-1130
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

13 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Product Code 66020933 RENASYS G Small with Soft Port - Lots #'s 2015100134, 2015100313, 2015100314, 2016040686, and 2016040687 - US ONLY  Product Code 66020934 RENASYS G Medium with Soft Port - Lots #'s 2015100135, 2015100315, 2015100316, 2015110540, 2016040715, and 2016040963  US ONLY Product Code 66020935 RENASYS G Large with Soft Port- Lots #'s 2015100282, 2015100317, 2015110542, and 2016041021  US ONLY  Product Code 66020936 RENASYS G X Large with Soft Port Lot # 2016041035  US ONLY Product Code 66800394 RENASYS Transparent Film Lots #'s 2014010176, 2014011449, 2014030463, 2014040241, 2014050736, 2014051132, 2014061169, 2014113986, 2015020655, 2015040522, 2015050927, 015060209, 2015071095, 2015101044, 2015110749, 2015120664, and 2015121019 - GLOBAL Product Code 66800494 RENASYS G Medium Kit Flat Drain Lots #'s 02014P, 05014D, 06914E, 13414K, 15414T, 16014CV, 18114AV, 23214D, 25214J, and 26515H  GLOBAL (NOT US) Product Code 66800495 RENASYS G Large Kit 19Fr Round Drain Lots #'s 00815K, 14014L, 23314E, 25214H, and 32214D  GLOBAL (NOT US) Product Code 66800496 RENASYS G Large Kit Flat Drain Lots #'s 00815N, 01215G, 02214J, 05014F, 09014K, 09914K, 16014F, 17514T, 24114D, 25214K, 28015M, and 31714H  GLOBAL (NOT US) Product Code 66800497 REANSYS G X-Large Kit 19Fr Round Drain Lot # 05014M  GLOBAL (NOT US) Product Code 66800932 RENASYS High Output Fistula Kit Lots #'s 07715M, 09214H, 15514G, 18814K, and 27915G  GLOBAL (NOT US) Product Code 66800933 RENASYS G Small with Soft Port Lots #'s 2014010183, 2014011414, 2014020037, 2014021119, 2014021324, 2014021837, 2014030094, 2014030840, 2014030933, 2014031770, 2014040674, 2014041232, 2014041489, 2014050297, 2014050582, 2014051447, 2014051561, 2014060367, 2014060603, 2014060606, 2014071097, 2014080670, 2014080729, 2014091593, 2014091612, 2014091896, 2014091951, 2014102569, 2014103236, 2014103501, 2014103566, 2014125085, 2014125464, 2015016495, 2015016793, 2015016824, 2015020606, 2015020633, 2015021230, 015030904, 2015030938, 2015031168, 2015050397, 2015050706, 2015051210, 2015051333, 2015060715, 2015060718, 2015060878, 2015070001, 2015070021, 2015070057, 2015070243, 2015091343, 2015100464, 2015100652, 2015100707, 2015100859, 2015100968, 2015101007, 2015120041, 2015120046, 2015120052, 2015120061, 2015120411, 2016010750, 39907, 40151, 43250, 3251, and 43252  GLOBAL (NOT US) Product Code 66800934 RENASYS G Medium with Soft Port Lots #'s 2014010306, 2014010307, 2014010965, 2014011574, 2014020362, 2014020972, 2014021207, 2014021208, 2014021930, 2014021931, 2014022059, 2014022086, 2014030302, 2014030816, 2014030934, 2014031153, 2014031404, 2014031758, 2014040175, 2014041509, 2014041510, 2014042119, 2014050158, 2014050207, 2014050345, 2014050586, 201405062, 2014051041, 2014051041, 2014060684, 2014060833, 2014061007, 2014061442, 2014061669, 2014070114, 2014070520, 2014070979, 2014071068, 2014080794, 2014080836, 2014080909, 2014090181, 2014090267, 2014091758, 2014091835, 2014092091, 2014102295, 2014102318, 2014114098, 2014114125, 2014114183, 2014114284, 2014124756, 2014124797, 2014125114, 2014125177, 2014125233, 2015020672, 2015020750, 2015020781, 2015020841, 2015021100, 2015021102, 2015031154, 2015040916, 2015050291, 2015050995, 015050996, 2015051048, 2015051382, 2015051409, 2015060395, 2015060402, 2015060912, 2015060921, 2015060979, 2015061078, 2015070313, 2015070335, 2015070348, 2015091344, 2015100024, 2015100672, 2015101328, 2015101360, 2015101522, 2015110440, 2015110767, 2015110809, 2015110931, 2015110988, 2015110989, 2015111015, 2015111261, 2015121208, 2015121237, 2016010018, 2016010772, 2016010790, 39908, 40152, 43249, 43432, 43433, 43434, 43435, and 43558  GLOBAL (NOT US) Product Code 66800935 RENASYS G Large with Soft Port Lots #s 2014010875, 2014010876, 2014010919, 2014010940, 2014011209, 2014011229, 2014011418, 2014020026, 2014020946, 2014021122, 2014021838, 2014021839, 2014022085, 2014030813, 2014030841, 2014031293, 2014031354, 2014031399, 2014040860, 2014041269, 2014041410, 2014042109, 2014042113, 2014050898, 2014051040, 2014051655, 2014060089, 2014060169, 2014060274, 2014061051, 2014061333, 2014061438, 2014080369, 2014080549, 2014090036, 014091306, 2014102445, 2014102629, 2014102650, 2014114359, 2014114527, 2014114577, 2014124708, 2014125271, 2014125307, 2014125307, 2015020993, 2015021023, 2015040809, 2015051050, 2015051077, 2015060486, 2015060493, 2015060494, 2015060507, 015061065, 2015061135, 2015061224, 2015061265, 2015070371, 2015100539, 2015100585, 2015100603, 2015100611, 2015110023, 2015110257, 2015110291, 2015110435, 2015120445, 2015120457, 2015120752, 2015120762, 2016010895, 2016011075, 39909, 40153, 43535, 43559, 43565, and 43714  GLOBAL (NOT US) Product Code 66800936 RENASYS G X Large with Soft Port Lots #'s 2014010874, 2014010961, 2014040956, 2014050897, 2014080970, 2014103611, 2015021068, 2015021444, 2015040678, 2015070796, 2015100001, 2015100272, 2015101377, and 2015120027 -  GLOBAL (NOT US) Product Code 66801255 RENASYS G 10Fr Round Drain Kit Lots #'s 01415G, 02015E, 04916J, 16914G, 2014050828, 1015G, 21015H, and 32214L -  GLOBAL (NOT US) Product Code 66801256 RENASYS G 10mm Flat Drain Kit Lots #'s 05516D, 05715H, 08915E, 11214JV, 11414AV, 11414BV, 16914H, 2013050783, 2013060968, 20915T, 32115L, and 32314M  GLOBAL (NOT US) Product Code 66801257 RENASYS 15Fr Channel Drain Kit Lots #'s 08915D, 16914J, 19615V, 2014030237, 2014060209, 20815K, 20915G, 23014L, 28815K,32215G, and 32814J  GLOBAL (NOT US) Product Code 66801258 RENASYS G 19Fr Round Drain Kit Lots #'s 05316P, 17014K, 2014030238, 20915K, and 32314T  GLOBAL (NOT US)
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AK, AL, AR, AZ, CA, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, WA, WI, Hawaii, and Puerto Rico Argentina, Australia, Bermuda, Brazil, Brunai, Canada, Curacao, Germany, Great Britain, Hong Kong, Ireland, Jordan, Malaysia, New Zeland, Peru, Saudi Arabia, Serbia, Singapore, South Africa, SriLanka, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film || Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns, flaps and grafts.
  • Manufacturer
  • Modelo / Serial
    Model No. 66800164; All pumps of this model are affected.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. || Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.
  • Manufacturer
  • Modelo / Serial
    Product Code Number: 66800694 Lot numbers: 50512962, 50512969, 50512974, 50513087, 50514672, 50513073, 50513074, 50517647, 50516110, 50539644, 50539645, 50539646, 50539647, 50555348, 50555349, 50555351, 50539648, 50546339, 50546340, 50548244, 50548245, 50548246, 50548247 and 50548248.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, GA, MA, MI, MO, MS,.NC, NY,OR, TN, and WI. and the countries of: Australia, Canada, China, England, Germany, Ireland and Singapore.
  • Descripción del producto
    ***REF 66800694***Qty 10***smith&nephew;***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/Fabrique au Mexique pour: Smith & Nephew, Inc., St. Petersburg, FL 33716***Smith & Nephew Medical Limited Hull HU3 2BN England***Lot 123456. || Product Usage: The product is a suction device used as an accessory to the foam dressing kits, which is used in conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to a wound.
  • Manufacturer
  • Modelo / Serial
    Product code:  66800912 - 800ml canister with solidifier 66800913 - 250ml canister with solidifier 66801066 - 800ml canister without solidifier 66800423 - 800ml canister with solidifier 66800058 - 250ml canister with solidifier Lot codes - M201498 thru M400299
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NH, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, and Puerto Rico; and the countries of: Austria, Australia, Belgium, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, UK, Greece, Israel, Italy, Malta, Netherlands, Norway, Paraguay, Russia, Saudi Arabia, Sweden, Thailand, Turkey, South Africa, Mexico, and Canada.
  • Descripción del producto
    Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
  • Manufacturer
  • Modelo / Serial
    Product code:  66800912 - 800ml canister with solidifier 66800913 - 250ml canister with solidifier 66801066 - 800ml canister without solidifier 66800423 - 800ml canister with solidifier 66800058 - 250ml canister with solidifier Lot codes - M201498 thru M400299
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NH, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, and Puerto Rico; and the countries of: Austria, Australia, Belgium, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, UK, Greece, Israel, Italy, Malta, Netherlands, Norway, Paraguay, Russia, Saudi Arabia, Sweden, Thailand, Turkey, South Africa, Mexico, and Canada.
  • Descripción del producto
    Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
  • Manufacturer
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