Recall Z-2790-2011 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Teleflex Medical
HUDSON RCI, Humidifier Adaptor, Rx only, Teleflex Medical, Research Triangle Park, NC 27709. Use to add water vapor to a dry medical gas for administration to a patient.
| Date | Jul 12, 2011 (initiated Jun 6, 2011) |
| Status | Terminated |
| Reason | The packaging may not have been properly sealed, and therefore the sterility of the product cannot be guaranteed. |
| Root cause | Packaging |
| Action | Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 6, 2011 to all affected customers. The letter described the product, problem, and the action to be taken. The letter instructs customers to discontinue use and quarantine the affected product. Customers must complete and return a Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customer Service. A representative will contact customers with instructions on how to return the affected product. Customers with no affected product are also instructed to complete and return the form to verify recei |
| Quantity | 228, 960 eaches |
| Distribution | Worldwide Distribution--USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, MI, MN, MO, MS, NM, NE, NY, OH, OK, PA, TX, VA, WI and WM and the countries of Japan, Philippines, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993355 | HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 Hudson Respiratory Care, Inc., May 24, 2000 |