Recall Z-2007-2014 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Teleflex Medical
Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
| Date | Jul 7, 2014 (initiated Jun 5, 2014) |
| Status | Terminated |
| Reason | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
| Root cause | Packaging change control |
| Action | Consignees were notified by letter on 06/06/2014. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K833974 | AQUAPAK 020 HUMIDIFIER ADAPTER Respiratory Care, Inc., Dec 16, 1983 |