FDA Medical Device Recalls (openFDA)
Porous Media Corporation: HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM
- Recall number
- Z-0935-2007
- Recalling firm
- Porous Media Corporation
- Product
- HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM
- Status
- Terminated
- Initiated
- 2007-04-26
- Posted
- 2007-06-20
- Terminated
- 2011-12-10
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K062091"]
- PMA numbers
- not on file
- Product code
- BTT
- Firm FEI
- 1000221012
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28