Reported Jun 12, 2013 · Terminated

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

Maytex Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Maytex Corp · 23521 Foley St · Hayward, CA · 94545-1676

Is this the product you have?

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

Lot codes and dates: 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
Amount recalled: 43,915 Cases

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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