Recall Z-0419-2016 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Teleflex Medical
Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
| Date | Dec 15, 2015 (initiated Apr 17, 2014) |
| Status | Terminated |
| Reason | Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed. |
| Root cause | Process control |
| Action | Teleflex sent an "Urgent Medical Device Recall Notification" dated April 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you have received products that are subject to this voluntary recall. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866- |
| Quantity | 2,600 ea |
| Distribution | US Distribution to the states of : AL, AZ, CA, GA, IL, KY, LA, MA, MI, MN, NJ, NY, NC, OH, OK, OR, PA, TN, TX and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031383 | MODEL 780 Hudson Respiratory Care, Inc., Jul 7, 2003 |