Class 2 Device Recall 2008 Series Hemodialysis Machine

Date Initiated by Firm: December 14, 2017

Create Date: March 20, 2018

Recall Status1:Open3, Classified

Recall Number: Z-1278-2018

Recall Event ID: 79478

Upcoming ESRD QIP Data Validity and Reliability Study

The Centers for Medicare & Medicaid Services has contracted with the RELI Group to conduct the upcoming ESRD QIP Data Validity and Reliability Study.

FDA MedWatch: Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling

January 12, 2018

FDA MedWatch: Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication

December 19, 2017

ESRD QIP PSR and PSC available on December 15

December 15, 2017

FDA Product Information Advisory - Albumin Human 25% Solution (AlbuRx 25)

November 9, 2017

Riomet (Metformin Hydrochloride Oral Solution): Recall - Microbial Contamination

November 27, 2017

FDA Alerts Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel

November 27, 2017

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls

November 17, 2017

Summary: Update on the efforts by the FDA to address IV fluid shortages exacerbated by Hurricane Maria and advice for hospitals in managing the shortage

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