Device product
Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Z-2012-2014
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-2012-2014
Official wording
Reason: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
Code information: Product Code: 006-40, Lot numbers: 041126, 042126, 043126, 044126, 053126, 054126, 055126, 056126, 057126, 058126, 068126, 069126, 070126, 075126, 077126, 078126, 079126, 086126, 087126, 088126, 089126, 090126, 097126, 111126, 120126, 121126, 122126, 123126, 128126, 155126 & 156126.
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.