Device product
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
Product summary
- Firm
- Teleflex Medical
- Event
- Event 70280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,779,607 units
- Official record key
device-enforcement:Z-1096-2015
Official wording
Reason: 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.
Derived failure modes
-
Foreign material or chemical contamination
foreign material