Skip to content
Recall Observatory FDA recall evidence

Device product

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

January 14, 2015

Class II

Product summary

Firm
Teleflex Medical
Event
Event 70280
Status
Terminated
Classification
Class II
Quantity
15,779,607 units
Official record key
device-enforcement:Z-1099-2015

Official wording

Reason: 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.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign material