Device Recall Hudson RCI Humidifier Adaptor, 040.

  • Model / Serial
    Product Code: 400340, Lot numbers: 001147, 061137, 313147, 059137, 010147, 293137, 038147, 225137, 558137, 362137, 202147, 425137, 301147, 263137, 366137, 076147, 316137, 424137, 012147, 155137, 147137, 597137, 478137, 235147, 278147, 228147, 013147, 303137, 523137, 023147, 206147, 336137, 279147, 481137, 618137, 179137, 025147, 248137, 086147, 252147, 392137, 533137, 551137, 191137, 563137, 270137, 042147, 502137, 080137, 299147, 207137, 022147, 516137, 165137, 387137, 104147, 645137, 220137, 494137, 578137, 385137, 305147, 183137, 390137, 650137, 383137, 041147, 186137, 299137, 246137, 389137, 531137, 027147, 006147, 266137, 236137, 297147, 116147, 189137, 491137, 008147, 208137, 191147, 057137, 480137, 229137, 309137, 611137, 107137, 313137, 163137, 568137, 420137, 474137, 231147, 281147, 234137, 100147, 216137, 300137, 472137, 328137, 485137, 159137, 203147, 353137, 590137, 082147, 556137, 614137, 161137, 469137, 488137, 035147, 194147, 223137, 641137, 489137, 475137, 197147, 024147, 044147, 200147, 203137, 509137, 477137, 213137, 205147, 030147, 594137, 349137, 580137, 190147, 416137, 256147, 033147, 262147, 471137, 413137, 338137, 103137, 149137, 410137, 297137, 346137, 426137, 200137, 569137, 287137, 463137, 575137, 102147, 470137, 582137, 286137, 032147, 307137, 193147, 104137, 290137, 101147, 467137, 572137, 261137, 036147, 197137, 282147, 647137, 103147, 527137, 554137, 331137, 512137, 259137, 505137, 560137, 047147, 125147, 156137, 128147, 305137, 343137, 196147, 465137, 476137, 284147, 391137, 189147, 524137, 078147, 039147, 483137, 334137, 145137, 479137, 549137, 365137, 072147, 253147, 026147, 545137, 283147, 132147, 153137, 407137, 151137, 243137, 136147, 029147, 186147, 227137, 518137, 122147, 356137, 259147, 114147, 194137 & 182137.
  • 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, 340ML W/040 ADAPTOR, INTL. || 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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

9 devices with a similar name

Learn more about the data here

  • 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: 003-40J, Lot numbers: 149147, 017147, 165147, 337137, 400137, 240137, 492137, 015147, 163147, 151147, 118147, 613137, 130137, 398137, 180137, 244137, 406137, 169147, 212137, 427137, 627137, 152147, 019147, 570137, 329137, 166147, 168147, 164147, 401137, 141147, 160147, 142147, 487137, 490137, 115147, 162147, 170147, 171147, 624137, 619137, 486137, 326137, 437137, 335137, 184137, 409137, 422137, 140147, 332137, 143147, 412137, 105147, 566137, 419137, 241137, 403137, 528137, 616137, 111147, 109147, 417137, 181137, 185137, 161147 & 146147.
  • 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/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
    Product Code: 005-40, Lot numbers: 005135, 015135, 017135, 029135, 010135, 035135, 006145, 003135, 018135, 034135, 019135, 023135, 028135, 010145, 004145, 008135, 009145, 002145, 030135, 002135, 031135, 016135, 022135, 026135, 021135, 008145, 032135, 007135, 004135, 007145, 009135, 027135, 001145, 005145, 012135, 006135, 020135, 033135, 013135, 001135, 011135, 036135, 025135, 014135 & 003145.
  • 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
    AQUA 540 SW, 540 W/040 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: 006-40, Lot numbers: 033136, 030136, 028136, 026136, 042146, 061146, 125136, 061136, 038146, 139136, 024136, 101136, 135136, 173136, 198136, 067136, 192136, 177136, 059136, 022146, 067146, 119136, 034136, 045146, 152136, 157136, 042136, 053136, 051146, 100136, 145136, 045136, 137136, 047136, 182136, 176136, 154136, 172136, 131136, 138136, 191136, 021146, 190136, 098136, 050146, 156136, 185136, 043136, 096136, 189136, 150136, 044136, 155136, 181136, 184136, 043146, 196136, 144136, 136136, 183136, 072136, 188136, 197136, 049146, 099136, 073136, 151136, 041136, 071136, 064146, 065146, 064136, 063136, 066136, 060146, 058136, 065136, 186136, 025136, 097136, 124136, 046136, 044146 & 066146.
  • 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 640 SW, 650ML W/040 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
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