As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing. This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the
Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been c
Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches wer
Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured b
FDA warns lab staff that use of BD SARS-CoV-2 Reagents for the BD Max System may lead to false positive results.
Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable Dail
ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, Moisturizer and Disinfectant sold in one liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).
The FDA is providing the most recent, interim post-approval study results for Abiomed's Impella RP System.
Transliquid Technologies LLC is voluntarily recalling all Mystic Shield Protection Topical Solution, manufactured by Mystic Intl S.A. de C.V in Mexico City, and packaged in an 8.45 ounce (250 ml) bottles, to the consumer level.
Arrow International is recalling the pumps because both devices have a part that may break, char, and discolor the motor connector wires.
On July 1, Dr. Kedar Mate takes over as president and CEO of the Institute for Healthcare Improvement. He says that now, more than ever, the industry needs to rely on a science- and evidence-based approach to problem-solving.
At an online summit hosted by the Massachusetts Coalition for Serious Illness Care, prominent Brigham and Women's surgeon and writer Atul Gawande, Blue Cross Blue Shield of Massachusetts CEO Andrew Dreyfus, and the Institute for Healthcare Improvement's Kate DeBartolo said they're committed to fixing racial disparities.
UVT, INC. is voluntarily recalling 38,830 liters of SANIDERM ADVANCED HAND SANITIZER, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)
Saniderm Products (Saniderm) is voluntarily recalling Saniderm Advanced Hand Sanitizer, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). In response to a recent news alert by the Food and Drug Administration
June 26, 2020 | Learn about specific leadership behaviors and system supports needed to address the mental health and well-being needs of caregivers, particularly during the COVID-19 pandemic.
On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiated a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health.
This new kind of medicine — called telehealth — swept across the normally change-resistant world of health care with astonishing speed. And it is transforming doctor-patient interactions in ways that will continue to evolve.
To mark the 25th anniversary of the American Journal of Managed Care, each issue in 2020 will include an interview with a healthcare thought leader. For the June issue, AJMC turned to Donald M. Berwick, MD, MPP, president emeritus and senior fellow at the Institute for Healthcare Improvement and former administrator of CMS.
As telehealth adoption takes off in response to the COVID-19 pandemic, quality analysts and health systems claim much is still unknown about the quality of these virtual visits.
June 19, 2020 | Explore the key components of a contact tracing model and the importance of engaging health care systems, community health workers, social workers, and public health departments.