Recall Z-2006-2014
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 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Codes / lots: Product Code: 003-40, Lot numbers: 088137, 093127, 095127, 096127, 098127, 099127, 101127, 103127, 105127, 107127, 111127, 112127, 113127, 114127, 115127, 116127, 117127, 118127, 119127, 120127, 121127, 122127, 123127, 124127, 125127, 126127, 127127, 128127, 129127, 130127, 131127, 132127, 133127, 134127, 135127, 136127, 138127, 140127, 143127, 144127, 146127, 147127, 149127, 150127, 151127, 152127, 153127, 158127, 160127, 162127, 164127, 165127, 166127, 167127, 168127, 169127, 170127, 171127, 172127, 173127, 175127, 176127, 178127, 179127, 180127, 182127, 183127, 185127, 186127, 187127, 188127, 189127, 190127, 191127, 192127, 193127, 196127, 197127, 199127, 201127, 202127, 203127, 205127, 206127, 208127, 210127, 212127, 214127, 216127, 218127, 219127, 220127, 221127, 234127, 235127 , 237127, 240127, 242127, 258127, 262127, 265127, 268127, 271127, 273127, 275127, 278127, 279127, 280127, 281127, 282127, 283127, 284127, 285127, 286127, 294127, 295127, 296127, 297127, 298127, 299127, 301127, 302127, 303127, 305127, 306127, 308127, 310127, 311127, 319127, 321127, 323127, 324127, 325127, 326127, 327127, 328127, 329127, 330127, 331127, 332127, 342127, 344127, 346127, 348127, 349127…
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-2006-2014
- 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-2005-2014 Class II | Aquapak 101 SW, 190, 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-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 |