FDA Recall
Terminated
Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.
Recall: Z-2015-2014
·
Initiated June 5, 2014
Recall
- Recall Number
- Z-2015-2014
- Event Number
- 68493
- Firm
- Teleflex Medical
- FEI Number
- 3005747797
- Product Code
- BTT
- Status
- Terminated
- Root Cause
- Packaging change control
- Initiated
- June 5, 2014
- Posted
- July 7, 2014
- Terminated
- July 2, 2015
- Address
- 4024 Stirrup Creek Dr, Durham, NC, 27703-9000
Description
Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.
Reason
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
Action
Consignees were notified by letter on 06/06/2014.
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.
Quantity
7,758,650 ea. (total for all types listed)