Recall Z-1451-2013— Maytex Corp

Name: FDA recall Z-1451-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-15

Class II · Terminated

Class II FDA medical device recall by Maytex Corp, initiated 2013-05-15, terminated 2013-10-29. It names one FDA 510(k) clearance: K964358. 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.. Reason: 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..

Recalling firm: Maytex Corp
Classification: Class II
Status: Terminated
Initiated: 2013-05-15
Terminated: 2013-10-29
Firm location: Hayward, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K964358 — AMSEAL SURGICAL FACE MASKAmerican Seal Co.·cleared 1997-02-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.