Device product
Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
Z-2014-2014
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-2014-2014
Official wording
Reason: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
Code information: Product Code: 006-40J, Lot numbers: 028126, 035126, 045126, 063126, 098126, 105126 & 106126.
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.