Device product
Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
Z-2009-2014
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-2009-2014
Official wording
Reason: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
Code information: Product Code: 003-40J, Lot numbers: 177127, 181127, 184127, 225127, 227127, 229127, 231127, 254127, 287127, 291127, 293127, 363127, 364127, 365127, 366127, 367127, 385127, 387127, 389127, 391127, 393127, 423127, 424127, 429127, 431127, 434127, 436127, 437127 & 445127.
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.