As a precautionary measure, T. Marzetti Company is voluntarily recalling all “Best By” dates of the following products that were distributed in Alabama, Florida, Georgia, Indiana, Kentucky, Louisiana, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia, because they may have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Consumers should not consume these products.  No illnesses have been reported in connection with the recalled items

Although these products are not ready-to-eat items and have baking instructions which, if followed, will reduce consumer risk, there remains some risk that the mishandling of this product prior to or without adequate baking may cause illness.

We are working in coordination with the Food and Drug Administration (FDA) and our supplier on this recall.

All affected distributors and retail customers are being notified and the affected products are being removed from store shelves.

Affected product should be destroyed or may be returned to the place of purchase for a full refund. Consumers with questions may contact 1-866-837-2758 between 8 a.m. and 5 p.m. Eastern Time.

• Updated information is now available. The list of retail consignees has been posted for recalls: 123-2017, Trafon Group Recalls Chicken and Pork Products Produced Without Benefit of Import Inspection (Nov 16, 2017)
• Evershing International Trading Company is recalling 16 ounces Coconut Tree Brand Frozen Shredded Coconut because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune system. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting in to the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. No illnesses have been reported to date.This coconut products were distributed in Ohio, Massachusetts, Washington, California, Oklahoma, Illinois, Michigan, New Jersey and New York. This Frozen Shredded Coconut product is package in 16 ounces plastic bags. This recall is limited to Lot SE07A1, but the lot number is only printed on the case. Therefore, any customer that purchased this product from January 3, 2017 through January 3, 2018, should return the product to place of purchase for full refund. Customers may also contact Evershing International Trading Company at (408) 975-9660 during hours of operation, Monday to Saturday from 9:00 am to 5:00 pm.

  The issue was discovered by testing performed by the State of Massachusetts.

  This voluntary recall is being made with the knowledge of the US Food and Drug Administration. We appreciate your assistance in this matte. Although these products are not ready-to-eat items and have baking instructions which, if followed, will reduce consumer risk, there remains some risk that the mishandling of this product prior to or without adequate baking may cause illness.

  We are working in coordination with the Food and Drug Administration (FDA) and our supplier on this recall.

  All affected distributors and retail customers are being notified and the affected products are being removed from store shelves.

  Affected product should be destroyed or may be returned to the place of purchase for a full refund. Consumers with questions may contact 1-866-837-2758 between 8 a.m. and 5 p.m. Eastern Time.

• ISSUE: The Agilis Steerable Introducer Sheath’s hemostatic valve, which prevents blood from flowing back through the valve, may fail due to an improper seal of the sheath hub. Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism).
  • Model numbers and lot numbers: STJ408309, STJ408310, STJG408324; All product lots
  • Manufacturing and Distribution Dates: January 1, 2017 to May 5, 2017

  The use of affected products may cause serious health consequences for patients, including death.

  BACKGROUND: The Agilis Steerable Introducer Sheath is used to insert and position various cardiovascular catheters in the heart, including on the left side of the heart through the wall of tissue that separates the right and left chambers of the heart (interatrial septum).

  The improper seal occurs when not enough glue is used to reattach the cap to the hub after reprocessing. Too much glue can also block the sheath valve and make the device unusable.

  RECOMMENDATION: Sterilmed has provided the following instructions for health care facilities and providers:

  • Examine inventory immediately to determine if you have this product.
  • Do not use any of the affected products, and return any unused product to the company.
  • Share this information with the appropriate staff at your facility.
  • Continue to monitor patients treated with the Sterilmed Reprocessed Agilis Steerable Introducer Sheath as normal.

  Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178