ESRD Network 18 - FDA Alerts & Recalls

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Date Faxed		FDA Recall, Alert, Communication
8/30/11		FDA Recall
		H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel

7/8/11		FDA Safety Announcement
		Nulojix (belatacept): Risk Evaluation and Mitigation Strategy (REMS)

5/13/11		FDA Recall
		Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs)

5/10/11		FDA Safety Announcement
		Weck hemo-o-Lok Ligating Clips

5/3/11		FDA Recall
		Coumadin Crystalline 5mg Tablets

4/4/11		FDA Recall
		Roche ACCU-CHEK FlexLink Plus Infusion Set: Class I Recall - Potential for Under-Delivery of Insulin

4/4/11		FDA Safety Announcement
		Soladek Vitamin Solution: Unapproved Product May Contain Dangerously High Levels of Vitamins A, D

3/21/11		FDA Recall
		American Regent Injectable Products: Recall - Visible Particulates in Products

3/21/11		FDA Recall
		H&P Industries Providine Iodine Prep Pads

3/3/11		FDA Recall
		B. Braun Outlook 400ES Safety Infusion System

1/20/11		FDA Recall
		CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for use with the Blood Volume Monitor

1/7/11		FDA Recall:
		Triad Alcohol Prep Pads, Alcohol Swabs, And Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

9/10/10		FDA Recall
		Fresenius Urgent Recall for AC Power Cords

8/16/10		FDA News Release
		FDA Proposes Withdrawal of Low Blood Pressure Drug

5/4/10		FDA Recall
		Issues Statement on Baxter's Recall of Colleague Infusion Pumps

4/8/10		FDA Drug Safety Communication
		Follow up to the Public Health Alert about Changes to the Heparin Sodium USP Monograph

3/3/10		FDA Recall
		Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall

3/1/10		FDA Recall
		LifeScan OneTouch® SureStep® Test Strips

2/17/10		FDA: Drug Safety Communication
		Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp

1/29/10		FDA: Urgent Recall
		Edwards Lifesciences Aquarius Hemodialysis System

1/25/10		FDA: Recall
		Nipro GlucoPro Insulin Syringes

10/11/09		FDA Recall
		Philips Heartstart Fr2+ Automated External Defibrillators (AED)

10/5/09		FDA Alert
		New USP Standards for Heparin Products

9/16/09		FDA Recall
		LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc.)

9/8/09		FDA Recalls & Alerts
		Myfrotic (mycophenolica acid) [1 page] – SAFETY ALERT
		Accusure Insulin Syringes (31G, ½cc, and 1cc) [1 page] – RECALL
		Serious Errors with Certain Blood Glucose Monitoring Test Strips – For Diabetic Patients and/or Their Caregivers [3 pages] – SAFETY ALERT
		FDA Public Health Notification: Potentially Fata Errors with GHD-PQQ Glucose Monitoring Technology [3 pages] – SAFETY ALERT

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To provide leadership and assistance to renal dialysis and transplant facilities in a manner that supports continuous improvement in patient care, outcomes, safety and satisfaction.

U.S. Food and Drug Administration (FDA) Alerts, Recalls and Communications

To provide leadership and assistance to renal dialysis and transplant facilities in a manner
that supports continuous improvement in patient care, outcomes, safety and satisfaction.

U.S. Food and Drug Administration (FDA)
Alerts, Recalls and Communications