Recall Z-0935-2007 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Porous Media Corporation
HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM
| Date | Jun 20, 2007 (initiated Apr 26, 2007) |
| Status | Terminated |
| Reason | The Intake filter of the Humidiflow kits may became detached from the module and fall onto the compressor cooling fan during patient treatment. (If the filter were to come in contact with the fan blades this could stop the fan from operating and cause the concentrator to overheat and interrupt the flow of oxygen to the patient) |
| Root cause | Other |
| Action | Customers were notified via a letter dated April 26, 2007. The letter describes the problem and product. Included with the letter, is a correction kit and installation instructions. The letter also urges the consignee to take an action to fill the attached form to confirm that the new intake filter restaint has been installed. |
| Quantity | 178 |
| Distribution | WORLDWIDE DISTRIBUTION: USA including states of GA, MO, FL, UT, CO, TX, MT, MN, PA, OH, AL, SC, VA, KY, IA, MA, TN, IL, NM, UT, NJ, IN, and WI, and countries of CANADA, MEXICO, and JAPAN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062091 | POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION Porous Media Corp., Aug 8, 2006 |