Summary Company Announcement Date: June 15, 2020 FDA Publish Date: July 08, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Company Name: Endologix® Inc. Brand Name: Brand Name(s) Product Description: Product Description Ovation iX system…
CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets
Summary Company Announcement Date: July 03, 2020 FDA Publish Date: July 08, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Use of the pump system potentially could cause over-infusion or under-infusion of therapy Company Name: CME America Brand Name: Brand Name(s) Product Description: Product Description Infusion System Administration Set (infusion set) Company…
Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate
Summary Company Announcement Date: July 07, 2020 FDA Publish Date: July 07, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter Company Name: Mylan Institutional LLC Brand Name: Brand Name(s) Product Description: Product Description Daptomycin for Injection Company Announcement Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional…
False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System – Letter to Clinical Laboratory Staff and Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test. In one study, the manufacturer found approximately three percent (3%) of results were false positive results. Recommendations The FDA recommends…
ITECH 361 Issues Voluntary Nationwide Recall of All Clean Hand Sanitizer and Moisturizer and Disinfectant Due to The Potential Presence of Undeclared Methanol (Wood Alcohol)
Summary Company Announcement Date: July 06, 2020 FDA Publish Date: July 06, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of methanol (wood alcohol). Company Name: ITECH 361 Brand Name: Brand Name(s) Product Description: Product Description Hand sanitizer Company Announcement ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand…
Arrow International Inc. Recalls Arrow AutoCAT®2 and AC3 Optimus® IABP Series Due to Possible Breakdown of Motor Connector Wires
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Arrow AutoCAT®2 and AC3 Optimus® Intra-Aortic Balloon Pump Series Model, Product Names, Product Codes, and Serial Numbers: See List of Affected Devices Manufacturing Dates: 08/01/2014 to 01/2020…
Consejos básicos para cocinar a la parrilla: Evite las enfermedades transmitidas por alimentos.
[embedded content] English Ésta es la estación de los picnics, las parrilladas y otras fiestas al aire libre. Pero comer al aire libre en un clima cálido presenta un reto de inocuidad alimentaria. Las bacterias en los alimentos se multiplican más rápido a temperaturas entre 40°F a 140°F (4.4 a 60°C), de manera que el…
Transliquid Technologies LLC Issues Voluntary Recall of Mystic Shield Protection Topical Solution Due to Presence of Undeclared Methanol for the States of California, Louisiana, Massachusetts, and Texas
Summary Company Announcement Date: July 02, 2020 FDA Publish Date: July 02, 2020 Product Type: CosmeticsDrugs Skin Care Products Reason for Announcement: Recall Reason Description Undeclared methanol Company Name: Transliquid Technologies LLC Brand Name: Brand Name(s) Mystic Shield Product Description: Product Description Mystic Shield Protection Topical Solution Company Announcement Transliquid Technologies LLC is voluntarily recalling…
UVT, INC. Issues Voluntary Nationwide Recall of SANIDERM ADVANCED HAND SANITIZER Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)
Summary Company Announcement Date: June 29, 2020 FDA Publish Date: June 29, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of methanol (wood alcohol) Company Name: UVT, INC. Brand Name: Brand Name(s) Product Description: Product Description Advanced Hand Sanitizer, 70% alcohol content Company Announcement UVT, INC. is voluntarily recalling 38,830 liters…
For Consumers: Seven Things Pregnant Women and Parents Need to Know About Arsenic in Rice and Rice Cereal
Español You may be surprised to learn that there is arsenic in rice. In fact, rice is not the only food or beverage that contains arsenic. It’s also found in vegetables, fruits, and many other foods. The FDA has been monitoring the presence of arsenic in food as part of its ongoing oversight of the…