Recall Z-1113-2020 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
TELEFLEX MEDICAL INC
HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit
| Date | Feb 7, 2020 (initiated Dec 13, 2019) |
| Status | Terminated |
| Reason | There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy. |
| Root cause | Device Design |
| Action | The firm initiated the recall by letter on 12/13/2019. The firm is seeking the return of the product. The firm requested the following actions be taken: "1. If you have affected stock, immediately identify all patients that are currently exposed to use of this product, discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To acknowledge receipt of this Urgent Medical Device Recall Notice or to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. |
| Quantity | 60467 devices |
| Distribution | nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162242 | Comfort Flo Humidification System Teleflexmedical, Inc., Jan 19, 2017 |