Category Archives: ~ politics petitions pollution &pop culture

FDA/USDA ~ December ~ Alerts & Safety ~ 2019


  • B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of twenty-two (22) lots of Blood Administration Sets. The recalled blood administration sets are used to administer blood from a container to a patient’s vascular system through an IV catheter inserted into a vein or central venous catheter.
    B. Braun identified through complaints and internal discrepancies the potential for leakage at the joint between the blood filters and tubing of these blood administration sets. Blood set leakage may result in delay in therapy due to the need to replace the set and blood product or result in the potential for microorganisms to enter the circulatory system creating a risk of bloodstream infection. To date there have been no reports of serious injury or death.Product Catalog Number:
    Lot Number
    GUIDID
    Product Description:
    477005
    61679395
    04046955202799
    Outlook® Safety Infusion System Y-type Blood Set
    477005
    61685454
    04046955202799
    Outlook® Safety Infusion System Y-type Blood Set
    490293
    61681734
    04046964539657
    Y-type Blood Set
    490314
    61674868
    04046964527180
    Y-type Blood Set
    490314
    61677175
    04046964527180
    Y-type Blood Set
    490314
    61678259
    04046964527180
    Y-type Blood Set
    490314
    61685087
    04046964527180
    Y-type Blood Set
    490425
    61674871
    04046964813702
    Y-type Blood Set
    490425
    61680607
    04046964813702
    Y-type Blood Set
    490425
    61685094
    04046964813702
    Y-type Blood Set
    490530
    61674878
    04046955203321
    Y-type Blood Set
    490530
    61677192
    04046955203321
    Y-type Blood Set
    490530
    61678186
    04046955203321
    Y-type Blood Set
    490530
    61681736
    04046955203321
    Y-type Blood Set
    490530
    61685105
    04046955203321
    Y-type Blood Set
    NF5140
    61681745
    04046964187483
    Safeline® Y-Type Blood
    Set
    Product Catalog Number:
    Lot Number
    GUIDID
    Product Description:
    NF5140
    61685109
    04046964187483
    Safeline® Y-Type Blood
    Set
    V2500
    61674884
    04046964188633
    Y-Type Blood Set
    V2500
    61677634
    04046964188633
    Y-Type Blood Set
    V2500
    61678262
    04046964188633
    Y-Type Blood Set
    V2500
    61680625
    04046964188633
    Y-Type Blood Set
    V2500
    61685110
    04046964188633
    Y-Type Blood Set
    A total of 43,026 units of the recalled blood administration sets were manufactured between June 11, 2019 and August 23, 2019 and distributed between June 11, 2019 and September 27, 2019. B. Braun notified its distributors and customers by certified mail on November 20, 2019 and is arranging for the return of all recalled blood administration sets. Distributors and customers that have affected inventory should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 1-800-227-2862 Monday through Friday, 8 a.m. to 6 p.m. (EST) for instructions to return the affected blood administration sets; and to arrange for either replacement of product or refund. The recalled blood administration sets were distributed only to the United States and Canadian markets.
    Consumers with questions regarding this recall, including arranging for replacement product or refund, can contact B. Braun Medical Inc.’s Customer Support Department at 1-800-227-2862 Monday through Friday, 8 a.m. to 6 p.m. (EST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.
    Adverse reactions or quality problems experienced with the use of this product should be reported to B. Braun’s Medical Information Department at 1-800-854-6851. Additionally, any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program:
    Complete and submit the report Online
    Regular Mail or Fax: 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
    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
    About B. Braun
    B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include ostomy and wound care, dialysis, nutrition, and pharmacy admixture. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
  • Lin’s Waha Int’l Corp of Syosset, NY is recalling its 8.11 OZ (230G) packages of Suantianyangmei Waxberry and Bingtangyangmei Waxberry because they contain undeclared sulfites and cyclamates. People who have severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products. Cyclamate is an unapproved ingredient.
    The recalled Suantianyangmei Waxberry and Bingtangyangmei Waxberry were distributed nationwide in retail stores. These products come in 8.11 OZ (230G) clear plastic containers. Suantianyangmei Waxberry is with UPC code 6948576407226 and date 03.12.2020 stamped on the box and Bingtangyangmei Waxberry is with UPC code 6948576407219 and date 02.13.2020 stamped on the box.
    No illnesses involving these products have been reported to date.
    The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by the Department’s Food Laboratory personnel revealed the presence of sulfites and cyclamates in these products which were not declared on the labels. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites. Analysis of the Suantianyangmei Waxberry and Bingtangyangmei Waxberry revealed they contained undeclared sulfites 13.88 milligrams and 12.85 milligrams per serving, respectively.
    Consumers who have purchased 8.11 OZ (230G) packages of Suantianyangmei Waxberry and Bingtangyangmei Waxberry are urged to return them to the place of purchase for a full refund. Consumers with questions may contact Selina Lin at 516-261-9521.
  • UNFI announced today a voluntary national recall of five-pound bags of its Wild Harvest® Organic All-Purpose Flour, Unbleached, with a Code of AA BEST IF USED BY 010820 CC 15:58 and UPC Code 711535509158. The recall is being issued for the potential presence of E. coli. During routine FDA sampling of the five-pound bag product, results were found to be positive for E.coli.
    E. coli can cause serious and sometimes life-threatening infections in infants, older people, pregnant women, and people with weakened immune systems. The most common symptoms of E. coli are diarrhea, abdominal cramps, nausea and vomiting, which develop within three or four days of eating contaminated food. The illness usually lasts about a week and most people recover without treatment. Guidance from FDA and the Centers for Disease Control (CDC) continues to warn that consumers should refrain from consuming any raw products made with flour and that all surfaces, hands and utensils should be properly cleaned after contact with flour or dough.
    To date, UNFI has not received any direct consumer reports of confirmed illnesses related to this product. This recall is being issued out of an abundance of care.
    This recall only affects the following code date of Wild Harvest® Organic All-Purpose Flour, Unbleached five-pound bags currently in stores or consumers’ pantries. No other types of Wild Harvest® Flour are affected by this recall.
    Wild Harvest® Organic All-Purpose Flour, Unbleached (sample label below) Package UPC: 711535509158 Best if Used by Date: 010820 CC 15:58 (can be found on top of the product, see sample below)
    Consumers are asked to check their pantries and dispose of the product affected by this recall. Consumers with questions may contact UNFI at 855-423-2630 (customer support is available seven days-a-week between 8:00 AM to 8:00 PM CST). Any consumers concerned about an illness should contact a physician.

December is Universal Human Rights Month


Wethepeople

The Universal Declaration of Human Rights (UDHR) was adopted by the United Nations General Assembly on December 10, 1948 without a dissenting vote. It is the first multinational declaration mentioning human rights by name, and the human rights movement has largely adopted it as a charter.