HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Pa
FDA device recall Z-0935-2007 · posted 2007-06-20 · Terminated
Recall details
- Recalling firm
- Porous Media Corporation
- Reason for recall
- 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)
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTT
- Quantity affected
- 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.
- Date initiated
- 2007-04-26
- Date posted
- 2007-06-20
- Date terminated
- 2011-12-10
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION (K062091) | Porous Media Corp. | 2006-08-08 |