Alaris™ Pump Modules Model 8100 Recalls
September 22, 2019
In a recall notification sent on April 15, 2019, Becton, Dickinson and Company (“BD”) informed clinicians that the bezel assemblies in certain Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017 were manufactured with a specific type of plastic material. BD condu[...]
Continue Reading
The Underbelly Of The Stem Cell Industry Exposed
August 28, 2019
The results of a joint investigation undertaken by The New Yorker and ProPublica that was published on May 7, 2019 entitled “The Birth-Tissue Profiteers” found that “alongside legitimate, scientifically proven treatments, an industry has sprung up in which specialized clinics offer[...]
Continue Reading
U.S. Obtains Injunction Against Stem Cell Products Manufacturer
July 31, 2019
In early June 2019, the Southern District of Florida granted the U.S. government’s motion for summary judgment against US Stem Cell Clinic LLC of Weston, Florida, US Stem Cell Inc. of Sunrise, Florida, and their Chief Scientific Officer Kristin Comella, Ph.D., holding that the defendants had adult[...]
Continue Reading
Allergan Textured Breast Implants Recalled At FDA’s Request
July 26, 2019
On July 24, 2019, the FDA issued a safety communication requesting Allergan to voluntarily recall certain breast implants and tissue expanders to protect patients from risks associated with certain textured breast implants. The macro-textured implants, like the BIOCELL textured implants manufactured[...]
Continue Reading
When Will The FDA Investigate The Metal In Filshie Clips?
March 29, 2019
The FDA issued a statemnet on March 15, 2019 entitled “Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions” in whi[...]
Continue Reading
Stryker Defibrillator Recall
March 3, 2019
On February 1, 2019, Stryker issued an “URGENT MEDICAL DEVICE SAFETY NOTICE & CORRECTION ACTION REQUIRED” regarding its LIFEPAK® 15 Monitor/Defibrillator, stating that “Stryker is conducting a voluntary Field Action for specific LIFEPAK 15 Monitor/Defibrillator devices that m[...]
Continue Reading
Are Filshie Clips Safe?
February 24, 2019
Millions of women in the United States have had Filshie Clips implanted as a means of permanent sterilization. The vast majority of these women apparently have not suffered any complications or adverse events regarding their Filshie Clips. Nonetheless, we receive inquiries on nearly a daily basis fr[...]
Continue Reading
