Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is m

FDA device recall Z-1451-2013 · posted 2013-06-04 · Terminated

Recall details

Recalling firm

Maytex Corp

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.

Action taken

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.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

FXX

Quantity affected

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 countr

Date initiated

2013-05-15

Date posted

2013-06-04

Date terminated

2013-10-29

Location

Hayward, CA

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