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U.S. Department of Health and Human Services

Class 3 Device Recall ThermoFlo 1 HME

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  Class 3 Device Recall ThermoFlo 1 HME see related information
Date Initiated by Firm February 19, 2015
Date Posted May 09, 2015
Recall Status1 Terminated 3 on August 29, 2017
Recall Number Z-1596-2015
Recall Event ID 70662
510(K)Number K903054  
Product Classification Condenser, heat and moisture (artificial nose) - Product Code BYD
Product ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17.

Used as a humidifier in a breathing circuit.
Code Information Product code: 6160, Batch number: 110208-50
Recalling Firm/
Manufacturer		 Arc Medical Inc
4296 Cowan Rd
Tucker GA 30084-4800
For Additional Information Contact Hal B. Norris
404-373-8300 Ext. 210
Manufacturer Reason
for Recall		 Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
FDA Determined
Cause 2		 Process control
Action Consignees were contacted by telephone on 02/19/2015.
Quantity in Commerce 1810 units
Distribution Distributed in CA and NC.
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 = BYD and Original Applicant = PHARMA SYSTEMS, INC.
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