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Recall Observatory FDA recall evidence

Device product

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

January 14, 2015

Class II

Product summary

Firm
Teleflex Medical
Event
Event 70280
Status
Terminated
Classification
Class II
Quantity
15,779,607 total units
Official record key
device-enforcement:Z-1095-2015

Official wording

Reason: 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.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign material