During the use of some ATAR extension cables, the cable was separating from the connector at the proximal end. The analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use.
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Novo Nordisk Recalls Cartridge Holders In Certain Novopen Echo® Insulin Delivery Devices Due to Potential Health Risks
Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo® batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents. NovoPen Echo® is used for insulin treatment by people with diabetes. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar. Novo Nordisk believes the risk of experiencing high blood sugar when using a device with an affected cartridge holder is low.
Federal judge enters consent decree against Alabama compounder Medistat
U.S. District Judge William H. Steele entered a consent decree of permanent injunction yesterday between the United States and Medistat RX LLC of Foley, Alabama, the company’s co-owners, Mark D. Acker and Timothy L. Fickling, and quality manager and pharmacist-in-charge V. Elaine Waller.
Voluntary Recall of CLIF BUILDER’S Bar Chocolate Mint Flavor, CLIF Kid Zbar Protein Chocolate Mint and CLIF Kid Zbar Protein Chocolate Chip Flavors
Clif Bar & Company is initiating a voluntary recall of CLIF® BUILDER’S® Bar Chocolate Mint flavor, and CLIF Kid Zbar® Protein Chocolate Mint and CLIF Kid Zbar® Protein Chocolate Chip flavors due to possible presence of undeclared peanuts and some tree nuts, including almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, walnuts and coconuts. Clif Bar & Company is taking this precautionary safety step for people who are allergic to peanuts and these listed tree nuts. People with an allergy to peanuts and these specific tree nuts run the risk of a serious or life-threatening allergic reaction.
Hardcore Formulations Issues Voluntary Nationwide Recall of Ultra-Sten and D-Zine Capsules Due to Labeling that it Contains Anabolic Steroids
Hardcore Formulations is voluntarily recalling all lots and expiration dates of Ultra-Sten and D-Zine capsules to the consumer level. These products are labeled to contain methylstenbolone (Ultra-Sten) and dymethazine (D-Zine), which are considered to be derivatives of anabolic steroids. The presence of these anabolic steroids in Ultra-Sten and D-Zine render them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall.
Raja Foods Issues Allergy Alert on Undeclared Milk In "Anarkali Peshawari Naan Bread. Upc 0-51179-99605-2. Manufactured July 1st, 2015 Thru July 1st, 2017"
Raja Foods LLC of Skokie, Il is recalling its 15 ounce package of “ANARKALI PESHAWARI NAAN” because they may contain undeclared MILK. People who have allergies to MILK run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy
Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors.
Dierbergs Markets Issues Allergy Alert on Undeclared Fish and Milk in Product
St Louis-based Dierbergs is recalling various Deli Products with multiple use by dates in all retail stores because undeclared fish (anchovy) in a Caesar dressing and undeclared milk in 2 Santa Fe wraps. People who have allergies to fish and dairy run the risk of serious or life-threatening allergic reaction if they consume these products.
Federal judge orders New York smoked fish company to stop sales due to food safety violations
A New York smoked fish company has been ordered by a federal court to stop selling its products, which were produced in a facility that was contaminated with Listeria monocytogenes (L. mono), until it can comply with food safety regulations.
FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas
The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN).