FDA-Device2014-07-16Class II

Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.

Teleflex Medical
Hazard

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Sold states
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.
Affected count
7,758,650 ea. (total for all types listed)
Manufactured in
4024 Stirrup Creek Dr, Durham, NC, United States
Products
Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2013-2014

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