Devices

Device Recall HUDSON RCI

  • 모델명 / 제조번호(시리얼번호)
    Product Code: 5-16028, Lot numbers: 01L1300279, 01A1400574, 73D1400255, 73F1400448, 73J1400537, 73A1500341 and 73C1500431; Product Code: 5-16035, Lot numbers: 01J1300471, 01J1300472, 01K1300050, 01K1300073, 01K1300578, 01L1300382, 01L1300383, 01L1300557, 01M1300073, 01M1300312, 01A1400226, 01A1400432, 01B1400083, 01B1400356, 01B1400357, 01C1400260, 73D1400097, 73E1400504, 73F1400449, 73G1400387, 73G1400597, 73H1400033, 73H1400332, 73J1400259, 73J1400260, 73J1400261, 73K1400130, 73K1400131, 73K1400132, 73K1400225, 73K1400226, 73K1400227, 73L1400236, 73L1400382, 73L1400383, 73L1400384, 73L1400489, 73L1400583, 73L1400608, 73A1500481, 73A1500482, 73B1500077, 73B1500078, 73B1500353, 73B1500529, 73B1500530, 73B1500531, 73C1500256, 73C1500257, 73C1500581 and 73D1500099; Product Code: 5-16037, Lot numbers: 01K1300143, 01K1300144, 01K1300346, 01K1300347, 01K1300579, 01L1300081, 01L1300280, 01L1300281, 01L1300384, 01L1300558, 01M1300074, 01M1300117, 01M1300213, 01M1300313, 01A1400121, 01A1400194, 01A1400433, 01A1400575, 01B1400084, 01B1400115, 01B1400242, 01C1400087, 01C1400088, 01C1400285, 73D1400256, 73D1400627, 73E1400270, 73E1400366, 73F1400189, 73G1400053, 73G1400176, 73H1400034, 73H1400161, 73H140033, 73H1400442, 73J1400538, 73J1400547, 73K1400341, 73K1400342, 73K1400343, 73K1400462, 73L1400098, 73L1400234, 73L1400235, 73L1400584, 73L1400609, 73M1400071, 73M1400072, 73M1400073, 73M1400192, 73M1400193, 73A1500342, 73A1500343, 73A1500344, 73A1500590, 73A1500589, 73B1500076, 73B1500532, 73C1500110, 73C1500111, 73C1500531, 73C1500532, 73C1500582, 73D1500096, 73D1500097 and 73D1500098; Product Code: 5-16039, Lot numbers: 01K1300469, 01L1300082, 01L1300083, 01L1300559, 01M1300214, 01A1400227, 01A1400576, 01B1400243, 01B1400478, 73C1400067, 73D1400340, 73E1400114, 73F1400353, 73G1400256, 73G1400377, 73J1400398, 73J1400408, 73K1400463, 73L1400196, 73L1400097, 73M1400194, 73A1500483, 73A1500484, 73A1500591, 73A1500592, 73C1500112, 73C1500113, 73C1500258, 73C1500259, 01L1300385, 01A1400122, 01C1400261, 73E1400115, 73G1400388, 73J1400399, 73A1500204, 73B1500533, 73C1500583, 01L1300155 and 01A1400453; Product Code: 5-16041, Lot numbers: 73B1500256, 01C1400406, 73D1400497, 73F1400095, 73J1400116, 73J1400133, 73K1400464 and 73K1400465.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.
  • 제품 설명
    HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. || Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.
  • Manufacturer
    Teleflex Medical
  • 1 Event

제조사

Teleflex Medical
  • 제조사 주소
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 35 건

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Device Recall Hudson RCI Humidifier Adaptor, 040
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 001-40J, Lot numbers: 001139 & 003139.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay and Zambia.
  • 제품 설명
    AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA || Product Usage: || The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
  • Manufacturer
    Teleflex Medical
Device Recall Hudson RCI Tracheal Tubes
  • 모델명 / 제조번호(시리얼번호)
    Catalog no. 5-22110, Lot no. 01M1300076.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution to the states of FL, GA, IL, KY, MA, MI, MO, MS, OH, TX, WA and WV., and to the countries of Canada and the Netherlands.
  • 제품 설명
    Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
  • Manufacturer
    Teleflex Medical
Device Recall Hudson RCI Humidifier Adaptor, 040.
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 000-40, Lot numbers: BE08, BG05 BG08, BM18, CB11 & CB17.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay and Zambia.
  • 제품 설명
    Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040 || Product Usage: || The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
  • Manufacturer
    Teleflex Medical
Device Recall Hudson RCI Humidifier Adaptor, 040.
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 003-40, Lot numbers: 062137, 060137, 038137, 039137, 054137, 088137, 445147, 052137, 051137, 380137, 055137, 167137, 176137, 271147, 356147, 585137, 260147, 625137, 131137, 113147, 279137, 281137, 083137, 285147, 090147, 295147, 374137, 621137, 387147, 093137, 404147, 088147, 333147, 059147, 058137, 120137, 374147, 484137, 642137, 249147, 116137, 350147, 345147, 257137, 506137, 040147, 501137, 143137, 646137, 606137, 119147, 177147, 049137, 154147, 574137, 250147, 129147, 336147, 042137, 355137, 408137, 087147, 406147, 317147, 182147, 213147, 226147, 209137, 567137, 552137, 211147, 337147, 643137, 236147, 632137, 433137, 564137, 620137, 623137, 652137, 452137, 192137, 354137, 133147, 396147, 044137, 322137, 176147, 178137, 214137, 323137, 407147, 605137, 293147, 294137, 639137, 166137, 306147, 264147, 138147, 604137, 034147, 534137, 271137, 099137, 190137, 371137, 369137, 137147, 225147, 239137, 651137, 237137, 550137, 517137, 401147, 004147, 064137, 127137, 386147, 056137, 100137, 157137, 224147, 398147, 365147, 129137, 248147, 622137, 183147, 265137, 351137, 275147, 258137, 432137, 158147, 283137, 399147, 074147, 405147, 367137, 068137, 292137, 579137, 269137, 352137, 453137, 058147, 115137, 256137, 548137, 247147, 250137, 147147, 515137, 135147, 633137, 635137, 644137, 268137, 530137, 158137, 160137, 415137, 381137, 263147, 547137, 588137, 418137, 082137, 126137, 204147, 364147, 390147, 128137, 206137, 219137, 144147, 629137, 083147, 363137, 303147, 221137, 101137, 150147, 348137, 395147, 448137, 051147, 142137, 262137, 095137, 201137, 252137, 571137, 155147, 112137, 114137, 359137, 308147, 280137, 050147, 141137, 599137, 139147, 156147, 177137, 630137, 261147, 373147, 497137, 544137, 274147, 383147, 359147, 097147, 172147, 212147, 188137, 371147, 097137, 288147, 289137, 541137, 247137, 157147, 421137, 345137, 154137, 272137, 284137, 266147, 085137, 342147, 195137, 205137, 253137, 170137, 102137, 135137, 153147, 106137, 379137, 257147, 046137, 245147, 324147, 286147, 298147, 319147, 214147, 198137, 361137, 020147, 040137, 405137, 310147, 122137, 609137, 538137, 318137, 174137, 631137, 172137, 328147, 344147, 211137, 218137, 540137, 393147, 287147, 361147, 169137, 430137, 321137, 282137, 309147, 444137, 175137, 607137, 626137, 018147, 124137, 092147, 381147, 610137, 041137, 139137, 133137, 175147, 272147, 184147, 171137, 095147, 311147, 617137, 043137, 136137, 458137, 581137, 435137, 222147, 349147, 403147, 173137, 054147, 400147, 235137, 320137, 450137, 306137, 640137, 218147, 441137, 105137, 109137, 573137, 111137, 274137, 434137, 576137, 510137, 117137, 375137, 246147, 243147, 238147, 373137, 602137, 208147, 232147, 081147, 273137, 276137, 439137, 440137, 648137, 268147, 110137, 270147, 561137, 215147, 278137, 089137, 555137, 140137, 557137, 559137, 060147, 148137, 131147, 461137, 460137, 446137, 185147, 255147, 071147, 442147, 077137, 164137, 449137, 087137, 152137, 106147, 304147, 482137, 037147, 075137, 217147, 382147, 289147, 495137, 045137, 459137, 302147, 377147, 180147, 537137, 209147, 119137, 110147, 126147, 132137, 162137, 319137, 016147, 628137, 179147, 583137, 308137, 239147, 455137, 513137, 456137, 593137, 048147, 079147, 094147, 098137, 240147, 603137, 251137, 522137, 498137, 529137, 159147, 315147, 376147, 050137, 392147, 085147, 438137, 168137, 341137, 339147, 048137, 443137, 224137, 064147, 368147, 073137, 442137, 056147, 138137, 043147, 290147, 397147, 358137, 338147, 150137, 503137, 123147, 507137, 204137, 300147, 071137, 291147, 221147, 314147, 312147, 084147, 343147, 445137, 237147, 070147, 241147, 514137, 229147, 089147, 028147, 219147, 031147, 080147, 273147, 377137, 277137, 296147, 341147, 331147, 526137, 394147, 340147, 072137, 254137, 402147, 457137, 379147, 577137, 649137, 067137, 520137, 220147, 368137, 543137, 376137, 586137, 107147, 216147, 388147, 226137, 108137, 304137, 242147, 134147, 090137, 348147 & 384147.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay and Zambia.
  • 제품 설명
    AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. || Product Usage: || The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
  • Manufacturer
    Teleflex Medical
Device Recall Hudson RCI Humidifier Adaptor, 040
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 003-40B, Lot numbers: 394137, 429137, 542147, 674147, 396137 & 312137.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay and Zambia.
  • 제품 설명
    AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI || Product Usage: || The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
  • Manufacturer
    Teleflex Medical
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