Device Recall Hudson RCI Humidifier Adaptor, 040

Product Code: 001-40J, Lot numbers: 001139 & 003139.

Anesthesiology Devices

2

No

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.

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.

Product Code: 000-40, Lot numbers: BE08, BG05 BG08, BM18, CB11 & CB17.

Anesthesiology Devices

2

No

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.

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.

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.

Anesthesiology Devices

2

No

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.

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.

Product Code: 003-40C, Lot numbers: 124147, 615137, 144137, 536137, 553137, 187137, 099147, 307147, 230147, 414137, 280147, 296137, 193137, 346147, 021147, 504137, 451137, 249137, 592137, 410147, 411137, 612137, 473137, 210137, 295137, 415147, 127147, 357147, 324137, 067147, 173147, 354147 & 355147.

Anesthesiology Devices

2

No

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.

AQUAPAK SW/EAU STERILE, 340 ML W/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.

Product Code: 003-40F, Lot numbers: 506147, 238137, 288137, 298137, 292147, 062147, 045147, 066147, 565137, 393137, 468137, 242137, 404137, 462147, 462137, 511137, 077147, 360137, 384137, 350137, 267137, 233147, 314137, 388137, 542137, 525137, 302137, 014147, 276147, 046147, 198147, 258147, 277147, 490147, 482147, 192147, 057147, 117147, 227147, 011147, 120147, 464137, 201147, 382137, 073147, 002147, 505147, 480147, 195147, 598137, 005147, 601137, 333137, 251147, 291137, 521137, 535137, 489147, 301137, 347137, 386137, 562137, 466137, 091147, 459147, 589137, 595137, 068147, 508137, 325137, 285137, 254147, 395137, 327137, 357137, 310137, 539137, 496137, 049147, 053147, 093147, 009147, 007147, 587137, 591137, 344137, 399137, 584137, 121147, 188147, 494147, 330137, 402137, 339137, 519137, 264137 & 260137.

Anesthesiology Devices

2

No

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.

AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. || 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.