Z-0935-2007

HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul...

Name: Z-0935-2007 HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul...
Creator: Porous Media Corporation
Published: 2007-04-26
License: https://open.fda.gov/license/

Pentair Filtration Solutions / initiated 2007-04-26 / Terminated

FDA source

Porous Media Corporation began a recall of HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM on 2007-04-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0935-2007
Status: Terminated
Initiated: 2007-04-26
Posted: 2007-06-20
Terminated: 2011-12-10
Recalling firm: Pentair Filtration Solutions
Product: HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
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)
FDA 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 in commerce: 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.
Product codes and lots: 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

Product code BTT

K062091Class IIPorous Media Humidiflow Humidifier for Universal HumidificationPorous Media Corp. / cleared 2006-08-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)