Alerts
- B. Braun Medical Inc.: FDA has issued a Safety Announcement regarding a Voluntary Nationwide Recall of Lot H3A744, 1 gram Cefepimefor Injection USP and Dextrose Injection USP Due to Visible Particulate Matter. FDA posted 10/15/2013.
- URGENT PRODUCT ADVISORY - Please be advised of critical shortage of Fresenius Medical Care North America (FMCNA) 1-liter normal saline product. Download FMCNA 2nd Notification issued September 13, 2013 [PDF format, size: 503Kbs].
- Wellness Pharmacy, Inc. Sterile Products: FDA has issued a Safety Announcment regading a recall Nationwide Voluntary Recall of Certain Sterile Products due to Laboratory Results Indicating Microbial Contamination FDA posted 08/29/2013.
- Covidien Monoject Prefill Flush Syringes: FDA has issued a Safety Announcment regading a recall - of syringes as not subjected to AutoClave sterilization process or mismatched syringe tipcap, syringe label, filled volume and wrapper. FDA Safety Alert posted 8/20/2013 and Covidien release issued 8/19/2013.
- Hydroxyethyl Starch Solutions: FDA has issues a Safety Communication: Boxed Warning on increased mortality and severe renal injury, and additional warning on risk of bleeding, for use of hydroxyethyl starch solutions in some settings. View FDA Safety Alert posted 6/24/2013 and original FDA Warning posted 6/11/2013.
- Endologix, Inc. has issued a Class 1 recall of its AFX Introducer System after reports Of dilator breaking during procedures. This recalled product was distributed and manufactured from April 1, 2013 through April 30, 2013 and distributed in the U.S. only in Florida, Indiana, Michigan, New Hampshire, New Jersey and New York. Affected lot numbers include 1079840, 1079843, 1079844, 1079845. Visit FDA website for details on the AFX Introducer System recall of May 13th, and to view an FDA update issued on May 18th.
- Pentec Health, Inc. has initiated a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding. The recall covers renal therapies that were compounded on or before May 2, 2013. Visit FDA website for details on Pentec Health Recall of 05/17/2013 or to read the May 15th Press Release.
- Hospira Issues a Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection Due to Brass Particulates For more information visit the FDA Safety Announcement webpage FDA Hospira Recall 03.29.2013, or download Hospira Press Release 03.29.2013 [PDF format, 29Kb] or FDA Hospira Recall 03.29.2013 in PDF format [162Kb].
- Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance For more information visit the FDA website Clinical Specialties Compounding Pharmacy recall page or download FDA alert 03.21.2013 in PDF format [184Kbs].
- Vascular Solutions Zerusa Ltd. Issues Recall of Guardian™ II and
Guardian™ II NC Hemostasis Valves For more information visit the FDA website Vascular Solutions Zerusa Ltd. recall page or download FDA alert 3.18.2013 in PDF format [163Kbs]. - Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of Magnesium Sulfate 2gm In Dextrose 5% In Water, 50ml For Injecton Due To Mold Contamination For more information visit the FDA website Medprep Consulting Inc. recall page or download FDA alert 03.16.2013 in PDF format [163Kbs]. Also access updated release containing a product list. Updated release page 03.20.13 or download FDA alert 03.20.13 in PDF format [166 Kbs].
- URGENT! Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS® (peginesatide) Injection For more information visit the FDA websites OMONTYs recall or download FDA alert 2.25.2013 in PDF format [91Kbs].
- FDA Safety Announcement: CareFusion 303, Alaris Pump Module, Model 8100: Class I Recall - Potential for Pump Malfunction To Stop Infusion For more information visit FDA website - CareFusion Alaris Pump Model 8100 or download KCER notification [8/23/2012] [PDF, 123Kb].
- FDA Safety Announcement: Smiths Medical Medfusion Model 4000 Syringe Infusion Pump: Class I Recall - System Errors May Cause Device Shutdown. For more information visit FDA website - Smiths Medical Medfusion Model 4000 Syringe Infusion Pump or download KCER notification [8/3/2012] [PDF, 93.5Kb].
- FDA Safety Announcement: CareFusion Alaris PC Unit, Model 8015: Class I Recall - Error Code. For more information visit FDA website - CareFusion Alaris PC Unit or download KCER notification [8/1/2012] [PDF, 93.5Kb].
- FDA Safety Announcement: B. Braun Infusomat Space Infusion System: Class I Recall - Potential for Breakage of Anti Free Flow Clip Catch. For more information visit FDA website - B. Braun Infusomat Space Infusion System or download KCER notification [8/1/2012] [PDF, 96Kb].
- Alert Update: FDA Safety Announcement: Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate - Recall Class 1. For more information visit FDA web site - FMC Naturalyte and Granuflo Acid Concentrate or download KCER notification [6/27/2012] [PDF, 101Kb].
- FDA Safety Announcement: Cefepime: Label Change- Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment. For more information visit FDA web site - Cefepime Label Change or download KCER notification [6/26/2012] [PDF, 112Kb].
- FDA Safety Announcement: Nidek Medical Products Mark 5 Nuvo, Nuvo 8, and Nuvo Lite Oxygen Concentrators: Class I Recall - Risk of Fire, Loss of Supplemental Oxygen. For more information visit FDA web site - Nidek Medical Products or download KCER notification [6/22/2012] [PDF 88Kb].
- Alert Update: Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion - For more information visit FDA web site - Sigma Spectrum or download KCER notification [6/19/2012] [PDF 88Kb].
- FDA Safety Announcement: Dialysate Concentrates Used in Hemodialysis - Alkali Dosing Errors View FDA alert or download KCER notification 5/25/2012. [PDF, 119Kb]
- FDA Safety Announcement: H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing. View Press Release or download KCER notification 8/30/2011. [PDF, 69.3Kb]
- FDA Safety Alert: Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter: View Press Release or download KCER notification 8/3/2011. [PDF, 72Kb]
- FDA Safety Announcement: Nulojix (belatacept): Risk Evaluation and Mitigation Strategy (REMS): View Press Release download KCER notification 7/8/2011. [PDF, 198Kb]
- FDA modifies dosing recommendations for Erythropoiesis-Stimulating Agents: View Press Release and related FDA Communication [Posted 6/27/2011]
- FDA Safety Announcement: Defibtech Lifeline and
ReviveR Automated External Defibrillators (AEDs) view FDA announcement [Posted 05/11/2011] or download KCER notification 5/13/2011. [PDF, 87Kb] - FDA Safety Announcement: Weck Hem-o-Lok Ligating Clips view FDA announcement [Posted 05/05/2011] or download KCER notification 5/10/2011. [PDF, 87Kb]
- FDA Safety Recall Announcement: Coumadin (warfarin sodium) Crystalline 5 mg Tablets view FDA announcement [Posted 05/03/2011] or download KCER notification 5/3/2011. [PDF, 88Kb]
- FDA Notification: H & P Industries Recall: Povidine Iodine Prep Pads - Potential Microbial Contamination view FDA announcement [Posted 03/18/2011] or download KCER notification 3/21/2011. [PDF, 175Kb]
- FDA Notification: American Regent Recall: Injectable Products - Visible Particulates in Products view FDA announcement [Posted 03/18/2011] or download KCER notification 3/21/2011. [PDF, 135Kb]
- B. Braun Recalls: Outlook 400ES Safety Infusion System, Model Number 621-400ES view FDA announcement [Posted 02/01/2011] or download KCER notification 3/1/2011. [PDF, 174Kb]
- Fresenius Medical Care North America Initiates Voluntary Recall of CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for use with the Blood Volume Monitor view press release or download KCER notification 1/20/2011. [PDF, 238Kb]
- FDA Notification: Recall - Triad Alcohol Prep Pads, Swabs, and Swabsticks - For more information visit FDA Web site -Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination [posted 1/6/2011] or download KCER notification [1/7/2011] [PDF, 182Kb]
- FDA Notification: Recall - AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter - For more information visit FDA Web site - AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform[Posted 1/5/2011] or download KCER notification[1/5/2011] [PDF, 196Kb]
- FDA Safety Announcement: American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection - For more information visit FDA Web site - American Regent Sodium Bicarbonate Injection or download KCER notification [12/29/2010] [PDF, 143Kb]
- FDA Safety Announcement: Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results - For more information visit FDA Web site - Abbott Glucose Test Strips or download KCER notification [12/22/2010] [PDF, 119Kb]
- FDA Safety Announcement: B. Braun addEASE Binary Connector: Class I Recall -Stopper Fragments May Enter Bag - For more information visit FDA web site - B. Braun addEase or download KCER notification [12/01/2010] [PDF 331Kb].
- Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion - For more information visit FDA web site - Sigma Spectrum or download KCER notification [11/15/2010] [PDF 172Kb].
- Triton Pole Mount Infusion Pump by WalkMed: Recall - For more information visit FDA web site - Triton or download KCER notification [11/11/2010] [PDF 132Kb]. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products. Report online or download FDA reporting forms and submit as directed.
- Heparin Sodium (B. Braun): Recall - Trace Contaminant For more information visit FDA web site or download KCER notification [PDF 173Kb].
- Amgen Initiates EPOGEN (Epoetin alfa) Voluntary Recall For more information download Amgen recall letter [PDF, 17Kb] and KCER notification [PDF, 224Kb]
- Fresenius Urgent Recall for AC Power Cords For more information download Fresenius Release [PDF,297Kb ]and KCER Notification [PDF,330Kb].
- Recall of BagEasy Manual Resuscitation Devices by Westmed, Inc. For more information visit FDA Web site (9/15/2010).
- Baxter HomeChoice Peritoneal Dialysis Cycler [PDF, 314KB]
- OneTouch SureStep Test Strips (LifeScan) [PDF, 198KB]
- Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication
- FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor [PDF-18KB]
- Edwards Lifesciences Inc., Aquarius Hemodialysis System [PDF, 12KB]
- Nipro Medical Corporation Issues a Voluntary Recall of All GlucoPro Insulin Syringes [PDF-18KB]
- Dexferrum (iron dextran injection) - Labeling Change [Page updated: 10/27/2009]
- Unomedical Issues Worldwide Recall of Certain Manual Pulmonary Resuscitators [Page updated: 10/7/2009]
- Philips Issues Worldwide Recall of Select Heartstart Fr2+ Automated External Defibrillators (10/03/2009)
- Warning & Adverse Reaction to MyFortic (Link to Myfortic 9.8.09. - PDF, 81KB)
- Warning on use of GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinine) strips & meters (link to files “CDH-PQQ Glucose Monitoring 8.25.09PATIENTS” - PDF, 120KB and “GDH-PQQ Glucose Monitoring 8.25.09 PRACTITIONERS” - PDF, 125KB
- Voluntary Recall of Accusure Insulin Syringes (link to file Accusure Insulin Syringes 8.24.09 - PDF, 90KB).
- A group of unknown individuals posing as Medicare representatives are soliciting personal identification information from physicians through various corrupt schemes. Once obtained, the personal information is being used to complete fraudulent Medicare provider applications for new practice locations. Once the new provider number is established, these individuals rapidly submit a large volume of claims to the Medicare Carrier for payment. For more information, download this article from Medicare. (6/16/2009)
- FDA Recall: Caraco Pharmaceutical Announces a Nationwide Voluntary Recall of All Lots of Digoxin Tablets (3/31/2009)
- FDA Recall: ZOLL AED Plus Defibrillator (2/12/2009). For more information about this recall, please see the company's online at: http://www.ZOLLAEDPlusbatteryhelp.com
- Baxter Press Release: FDA Classifies Recent Urgent Device Correction on Baxter´s Colleague Infusion Pump as a Class I Recall (Press release 3/11/09)
- Peanut Butter Recall:
- FDA Recall: Peanut Product Recall List.
- General information on FDA recall resource page including announcements in different languages.
- FDA Recall: Premier Nutrition Bars (1/20/2009)
- FDA Recall: Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps (1/23/09)
- FDA Reports: Clinical Study of Innohep Stopped Early (12/2/2008)
- FDA Reports: Nationwide Recall of Mislabeled ReliOn Insulin Syringes(11/5/2208)
- MMWR: Infection Control Requirements for Dialysis Facilities and Clarification Regarding Guidance on Parenteral Medication Vials
- FDA Reports: Nationwide Recall of Mislabeled ReliOn Insulin Syringes(11/5/2208)
- Clarification Regarding Guidance on Parenteral Medication Vials (August 15, 2008)
- Ortho Biotech announced a voluntarily recall of manufacturing lot (P114942A) of Epoetin alfa (Procrit). View Press Release and letter to providers for more details.
- Voluntary Recall of HACH SteriChek Total Chloramines and Residual Chlorine Reagent Strips
- Urgent Recall of BD 60 ml Luer-Lok™ Syringes [PDF, 294Kb]
- FDA MedWatch - B. Braun's Supplier Recall of Heparin (3.21.08)
- CDC Update to Recall of Baxter Heparin (1.19.08)
- Urgent Recall of Baxter Heparin (1.17.08) [PDF, 1.2M]
- FDA Revises Recommendations Regarding ESAs - Full details for dosing and monitoring patients using ESAscan be found on the FDA Web site.