Teleflex Medical: Medical Device Recall in 2015 - (Recall #: Z-1108-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 14, 2015

Date Posted: February 18, 2015

Recall Number: Z-1108-2015

Event ID: 70280

Reason for Recall:

The packages may contain foreign material (black particles).

Status: Terminated

Product Quantity: 15,779,607 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated