| ||Class 2 Device Recall Comfort EarLoop Face Mask |
||June 04, 2013
||Terminated on October 29, 2013
|Recall Event ID
Mask, surgical -
||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.
||All cases of item #: 3100 face mask with PO #.
PO #, Date of receipt:
002-02 , 3/24/10;
253-04 , 12//192012
23521 Foley St
|For Additional Information Contact
|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.
|Labeling False and Misleading
||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: firstname.lastname@example.org 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: email@example.com Monday through Friday, 8:30 AM to 5:00 PM Pacific Time.
|Quantity in Commerce
||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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = FXX and Original Applicant = AMERICAN SEAL CO.