Device Recall Hudson RCI

  • Model / Serial
    Catalog Number: 780-96, Lot numbers: 02L1300073 & 02A140133.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including the states of CA, FL, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, PA, TN, TX and VA, and the countries of Argentina, Chile, Colombia, and the Philippines
  • Product Description
    Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

35 devices with a similar name

Learn more about the data here

  • Model / Serial
    Product Code: 001-40J, Lot numbers: 001139 & 003139.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • Model / Serial
    Catalog no. 5-22110, Lot no. 01M1300076.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
  • Manufacturer
  • Model / Serial
    Product Code: 000-40, Lot numbers: BE08, BG05 BG08, BM18, CB11 & CB17.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • Model / Serial
    Product Code: 003-40B, Lot numbers: 394137, 429137, 542147, 674147, 396137 & 312137.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
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