Device product
Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Z-2007-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 68493
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,758,650 ea. (total for all types listed)
- Official record key
device-enforcement:Z-2007-2014
Official wording
Reason: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
Code information: Product Code: 003-40C, Lot numbers: 109127, 155127, 157127, 174127, 195127, 222127, 277127, 335127, 337127, 384127, 422127, 425127, 497127 & 500127.
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.
Derived failure modes
-
Unknown
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.