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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1451-2013