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U.S. Department of Health and Human Services

Class 2 Device Recall Humidiflow

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  Class 2 Device Recall Humidiflow see related information
Date Initiated by Firm April 26, 2007
Date Posted June 20, 2007
Recall Status1 Terminated 3 on December 10, 2011
Recall Number Z-0935-2007
Recall Event ID 37863
510(K)Number K062091  
Product Classification Respiratory Gas Humidifier - Product Code BTT
Product HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM
Code Information 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  
Recalling Firm/
Manufacturer		 Porous Media Corporation
1350 Hammond Rd
Saint Paul MN 55110-5865
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BTT and Original Applicant = POROUS MEDIA CORP.
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