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Best Practices for Collecting and Addressing Anonymous Grievances

2019-03-14T15:44:27+00:00March 14th, 2019|

Although all patients have the right to file a grievance without fear of reprisal or denial of services, some patients may still not feel comfortable. One of the requirements for an internal grievance process is that patients are provided with an option to file a grievance anonymously. In January, the ESRD NCC hosted the first

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall

2018-12-03T16:04:15+00:00December 3rd, 2018|

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s

Class 2 Device Recall AMIA Automated PD Cycler

2018-08-22T13:13:46+00:00August 22nd, 2018|

Class 2 Device Recall AMIA Automated PD Cycler Tuesday, August 21, 2018 Baxter Healthcare Corporation has issued a recall for the following power cords: AMIA Automated PD Cycler, Product Code: 5C9320 Kaguya PD System, Product Code: T5C8500 Read More

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall

2018-08-08T18:21:59+00:00August 8th, 2018|

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial Wednesday, August 1, 2018 AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of

Zoll LifeVest 4000 Wearable Cardioverter Defibrillator

2018-08-08T19:30:15+00:00August 1st, 2018|

UPDATE: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication Wednesday, July 25, 2018 In January 2018, the FDA issued a Safety Communication alerting patients and health care providers that the LifeVest 4000 may fail to deliver a life-saving shock to a patient if the device

FDA Updates on Valsartan Recalls

2018-08-29T14:25:43+00:00July 26th, 2018|

FDA Updates on Valsartan Recalls Wednesday, July 25, 2018 Investigation ongoing – statement to be updated as more information is available FDA publishes a list of valsartan-containing products not part of the recall Update [7/24/2018] FDA is updating health care professionals and consumers on the agency’s progress in responding to the ongoing recalls of valsartan, which

Hospira Issues Voluntary Nationwide Recall

2018-07-18T16:04:05+00:00July 18th, 2018|

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions. Daptomycin for Injection has been associated with reports of adverse events indicative of

Fluoroquinolone Antibiotics

2018-08-08T19:39:57+00:00July 11th, 2018|

Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects Wednesday, July 11, 2018 Fluoroquinolone antibiotics are approved to treat certain serious bacterial infections, and have been used for more than 30 years. They work by killing or stopping the growth of bacteria that can cause illness. Without

HeartMate 3™ Left Ventricular Assist System: Class I Recall

2018-05-25T13:13:12+00:00May 25th, 2018|

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can

Class 2 Device Recall 2008 Series Hemodialysis Machine

2018-05-25T13:22:43+00:00May 21st, 2018|

Class 2 Device Recall 2008 Series Hemodialysis Machine Fresenius Medical Care Renal Therapies is recalling its dialyzer, high permeability with or without sealed dialysate system, 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number)

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