HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM
This recall has been terminated (originally issued June 20, 2007).
- Company
- Porous Media Corporation
- Recall Initiated
- April 26, 2007
- Posted
- June 20, 2007
- Terminated
- December 10, 2011
- Recall Number
- Z-0935-2007
- Quantity
- 178
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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)
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.
Lot / Code Info
Model # HMK-RM Lot # 072849001 Serial #''s: 1009202067, 1027061A, 100920067, 1109061, 102020061B, 102020061 (1009202067 has 28 Humidiflow kits ;1027061A has 29 kits;100920067 has 20 kits;1109061 has 42 kits;102020061B has 20 kits;102020061 has 39 kits0
Root Cause
Other
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.