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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = BYD
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