Recall Z-2005-2014
Teleflex Medical · initiated June 5, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor
Codes / lots: Product Code: 001-40J, Lot numbers: 001129 & 002129.
Reason for recall
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
FDA-determined cause: Packaging change control
Action taken
Consignees were notified by letter on 06/06/2014.
Details
- Recall number
- Z-2005-2014
- Initiated
- June 5, 2014
- Posted by FDA
- July 7, 2014
- Terminated
- July 2, 2015
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Quantity
- 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.
- Recalling firm
- Teleflex Medical, Durham, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2003-2014 Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas…The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect… | 06/05/2014Terminated |
| Z-2004-2014 Class II | Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2006-2014 Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2007-2014 Class II | Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2008-2014 Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2009-2014 Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2010-2014 Class II | Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2011-2014 Class II | Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2012-2014 Class II | Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2013-2014 Class II | Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2014-2014 Class II | Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2015-2014 Class II | Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2016-2014 Class II | Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2017-2014 Class II | Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |