PlainRecalls
FDA Devices Moderate Class II Terminated

Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

Reported: July 16, 2014 Initiated: June 5, 2014 #Z-2010-2014

Product Description

Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

Reason for Recall

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

Details

Recalling Firm
Teleflex Medical
Units Affected
7,758,650 ea. (total for all types listed)
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.
Location
Durham, NC

Frequently Asked Questions

What product was recalled?
Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.. Recalled by Teleflex Medical. Units affected: 7,758,650 ea. (total for all types listed).
Why was this product recalled?
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 16, 2014. Severity: Moderate. Recall number: Z-2010-2014.