Device product
Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Z-2011-2014
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-2011-2014
Official wording
Reason: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
Code information: Product Code: 006-40C, Lot numbers: 029126, 036126, 065126, 071126, 076126 & 091126.
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.