Device product
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
Product summary
- Firm
- Teleflex Medical
- Event
- Event 70280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,779,607 units
- Official record key
device-enforcement:Z-1101-2015
Official wording
Reason: 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.
Derived failure modes
-
Foreign material or chemical contamination
foreign material