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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70280

15 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 14, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Teleflex Medical

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

15 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 15

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.

Z-1095-2015
Recall number
Z-1095-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 total units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

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

Distribution pattern

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.

device · product 2 of 15

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.

Z-1096-2015
Recall number
Z-1096-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

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

Distribution pattern

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.

device · product 3 of 15

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.

Z-1097-2015
Recall number
Z-1097-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

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.

Distribution pattern

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.

device · product 4 of 15

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.

Z-1098-2015
Recall number
Z-1098-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

Product Code: 003-40B, Lot numbers: 394137, 429137, 542147, 674147, 396137 & 312137.

Distribution pattern

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.

device · product 5 of 15

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.

Z-1099-2015
Recall number
Z-1099-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

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.

Distribution pattern

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.

device · product 6 of 15

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.

Z-1100-2015
Recall number
Z-1100-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

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.

Distribution pattern

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.

device · product 7 of 15

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.

Z-1101-2015
Recall number
Z-1101-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

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.

Distribution pattern

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.

device · product 8 of 15

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.

Z-1102-2015
Recall number
Z-1102-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

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.

Distribution pattern

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.

device · product 9 of 15

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.

Z-1103-2015
Recall number
Z-1103-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

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.

Distribution pattern

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.

device · product 10 of 15

AQUAPAK SW/EAU STERILE, 650 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.

Z-1104-2015
Recall number
Z-1104-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

Product Code: 006-40C, Lot numbers: 040136, 062136, 029136, 013146, 083146, 178136, 048136, 171136, 074136, 104136, 020146, 060136, 039146, 035136 & 087136.

Distribution pattern

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.

device · product 11 of 15

AQUAPAK 640 SW, 650ML 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.

Z-1105-2015
Recall number
Z-1105-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

Product Code: 006-40F, Lot numbers: 147136, 103146, 015146, 102136, 153136, 023146, 040146, 001146, 056146, 115136, 052146, 132136, 008146, 110136, 159136, 165136 & 014146.

Distribution pattern

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.

device · product 12 of 15

AQUAPAK 640 SW, 650ML 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.

Z-1106-2015
Recall number
Z-1106-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

Product Code: 006-40J, Lot numbers: 028146, 075136, 083136, 103136, 111136, 113136, 146136, 029146, 007146, 114136, 034146, 068136, 126136, 033146 & 112136.

Distribution pattern

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.

device · product 13 of 15

ADAPTOR, 040 HUM, 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.

Z-1107-2015
Recall number
Z-1107-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

Product Code: 400040, Lot numbers: BE15 & BM17.

Distribution pattern

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.

device · product 14 of 15

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.

Z-1108-2015
Recall number
Z-1108-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

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.

Distribution pattern

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.

device · product 15 of 15

AQUAPAK 640 SW, 650ML 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.

Z-1109-2015
Recall number
Z-1109-2015
Initiated
January 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
15,779,607 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packages may contain foreign material (black particles).

Code information

Product Code: 400640, Lot numbers: 002146, 018136, 039136, 022136, 143136, 109136, 134136, 053146, 180136, 069146, 080136, 169136, 048146, 086136, 006146, 175136, 063146, 037146, 055146, 032146, 049136, 057136, 195136, 193136, 012146, 082136, 024146, 070136, 088136, 020136, 031146, 035146, 092136, 149136, 170136, 019136, 107136, 016146, 025146, 160136, 090136, 130136, 140136, 030146, 003146, 095136, 059146, 161136, 166136, 068146, 079136, 141136, 046146, 054136, 018146, 105136, 194136, 162136, 036146, 010146, 057146, 058146, 009146, 077136, 011146, 163136, 047146, 133136, 142136, 148136, 122136, 055136, 054146, 078136, 017146, 085136, 050136, 056136, 084136, 108136, 094136, 062146, 091136, 069136, 158136, 106136, 174136, 004146, 089136, 121136, 117136, 051136, 164136, 026146, 118136, 093136, 168136, 179136, 167136, 019146, 123136, 041146, 129136, 005146, 052136, 128136, 116136 & 021136.

Distribution pattern

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.