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U.S. Department of Health and Human Services

Class 2 Device Recall Comfort EarLoop Face Mask

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  Class 2 Device Recall Comfort EarLoop Face Mask see related information
Date Initiated by Firm May 15, 2013
Date Posting Updated June 04, 2013
Recall Status1 Terminated 3 on October 29, 2013
Recall Number Z-1451-2013
Recall Event ID 65160
510(K)Number K964358  
Product Classification Mask, surgical - Product Code FXX
Product Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA

Ear-loop face mask for basic medical/dental procedures.
Code Information All cases of item #: 3100 face mask with PO #. , PO #, Date of receipt:

809-01, 2/5/08;, 837-02, 7/29/08;, 852-03, 10/10/08;, 901-01, 2/3/09;, 921-02, 6/8/09;, 923-03, 7/8/09;, 926-04, 8/26/09;, 931-05, 11/10/09;, 942-06, 12/16/09;, 001-01, 2/17/10;, 003-03, 4/12/10;, 002-02 , 3/24/10;, 003-03A, 7/23/10;, 042-04, 11/29/10;, 105-01, 1/31/11;, 117-02, 4/29/11;, 127/03, 7/8/11;, 147-04, 12/16/11;, 202-01, 3/8/2012;, 224-02, 5/24/2012;, 235-03, 9/12/2012;, 253-04 , 12//192012

Recalling Firm/
Maytex Corp
23521 Foley St
Hayward CA 94545-1676
For Additional Information Contact Lauren Kwon
Manufacturer Reason
for Recall
Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of "Differential Pressure of only 1.6 Delta P (mm H2O/cm2)" as indicated on the box/package of the product; and also product manufactured between 2008 - 2012 cannot be guaranteed as Fluid Resistant.
FDA Determined
Cause 2
Labeling False and Misleading
Action The firm, Maytex Corporation, sent a "MEDICAL DEVICE SAFETY NOTICE" dated May 15, 2013, to all its customers. The notice described the product, problem and actions to be taken. The customers were instructed to immediately contact your medical professional for treatment and contact Maytex Corporation to file a complaint should any illness or injury occur; discontinue use of the product if you detect any potential health hazards; if this product has been further sold or distributed, notify your customers to the retail level and send copies of safety notice to customer/users; and complete and promptly return the enclosed Medical Device Safety Notice Return Response Acknowledgement and Receipt form via mail to: Maytex Corporation 23521 Foley Street, Hayward CA 94545; fax at; 510-786-0209; email: www.maytex18@aol.com or by delivery to Maytex Corporation. Maytex Corporation has temporarily taken down their Website at www.maytexcorp.com to correct the wrong product specifications as described in the notice. If you have any questions, contact Maytex Corporation at 1-800-462-9839 or email: maytex18@aol.com Monday through Friday, 8:30 AM to 5:00 PM Pacific Time.
Quantity in Commerce 43,915 Cases
Distribution Worldwide distribution: USA (nationwide) including states of: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, MA, MD, ME, MI, MN, MO, MT, NE, NH, NJ, NM, NY, OK, OR, PA, PR, TN, TX, UT, WA, and WI; and country of: Mexico.
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 = FXX and Original Applicant = AMERICAN SEAL CO.