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The following Web Notifications represents a new form of Notification for CDRH.Web Notifications are intended to augment the existing Safety Notification program and provide a mechanism to quickly disseminate device–related safety information beneficial to healthcare providers, but not appropriate for our existing forms of Notifications.Web notifications may be used in instances where the available information is limited, changing, and/or the Center may not be able to make specific recommendations, but would like to provide the information that we have to the healthcare community in a timely fashion.Web Notifications will be updated as additional information becomes available so you are encouraged to check back at this site.

Type	Date Issued	Title	Text	PDF
Web Notification	11/25/2003 Updated October 18, 2004	Final Update of Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Sirolimus-eluting Coronary Stent
Web Notification	12/19/2003 Updated May 7, 2004	Counterfeit Polypropylene Mesh
Web Notification	10/31/2002 Updated May 7, 2004	Complications Related to the Use of Bone Cement and Bone Void Fillers in Treating Compression Fractures of the Spine
Web Notification	10/23/2002	Non-Corrective Decorative Contact Lenses Dispensed Without a Prescription
Web Notification	7/24/2002 Updated: 9/25/2003	Risk of Bacterial Meningitis in Children with Cochlear Implants

Type	Date Issued	Title	Text	PDF
Public Health Notification	4/2/2004	Paralysis from Absorbable Hemostatic Agent
Public Health Notification	12/18/2003 Updated 3/30/2004	Safety Tips for Preventing Hospital Bed Fires
Public Health Notification	12/17/2003	Updated Data on Mortality Associated with Medtronic AVE AneuRx® Stent Graft System
Public Health Notification	12/19/2002	Diathermy Interactions with Implanted Leads and Implanted Systems with Leads
Notice	7/12/2002	PVC Devices Containing the Plasticizer DEHP
Notice	11/2/2001	Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients
Public Health Advisory	7/20/2001	Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels
Notice	4/27/2001	Problems with Endovascular Grafts for Treatment of Abdominal Aortic Aneurysm (AAA)
Notice	3/13/2001	Lead Exposure from Dental Films Stored in Lead-Lined Table-top Containers
Notice	10/11/2000	Serious Injuries from Microwave Thermotherapy for Benign Prostatic Hyperplasia
Notice	8/29/2000	Potential for Injury from Circumcision Clamps
Public Health Advisory	7/10/2000	Risk of Electromagnetic Interference with Medical Telemetry Systems
Notice	10/8/1999	Complications Related to the Use of Vascular Hemostasis Devices
Public Health Advisory	9/10/99	Infections from Endoscopes Inadequately Reprocessed by an Automated Endoscope Reprocessing System
Safety Alert	5/11/99	Potential Cross-Contamination Linked to Hemodialysis Treatment
Notice	5/4/99	Hypotension and Bedside Leukocyte Reduction Filters
Advisory	2/22/99	Glass Capillary Tubes: Joint Safety Advisory About Potential Risks
Advisory	2/4/99	Explosions and Fires in Aluminum Oxygen Regulators
Advisory	12/29/98	FDA Medical Device Malfunction
Notice	10/8/98	NIR ON Ranger w/SOX Premounted Stent System
Notice	9/28/98	Important Information on Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators
Notice	9/25/98	Illegal Promotion of Contact Lenses
Notice	8/3/98	Electrical Hazards Associated With Lead Wires and Cables
Public Health Advisory	5/21/98	Need for CAUTION When Using Vacuum Assisted Delivery Devices
Safety Alert	4/13/98	Warning Regarding the Use of the AbTox Plazlyte™ Sterilization System
Public Health Advisory	3/20/98	Interference Between Digital TV Transmissions and Medical Telemetry Systems
Notice	3/13/98	Potential Hypersensitivity Reactions To Chlorhexidine-Impregnated Medical Devices
Safety Alert	3/12/98	Supplemental Information Regarding: Failure of Isocam II, Dual-Headed Nuclear Medicine Gamma Camera
Notice	2/13/98	Failure of Isocam II, Dual-Headed Nuclear Medicine Gamma Camera
Notice	10/16/97	Update to Radioactivity in Radiation Protection Devices
Notice	8/13/97	Vacuum Loss in Electronic Resonating Components
Notice	8/5/97	Update to Radioactivity in Radiation Protection Devices
Public Health Advisory	7/25/97	Limitations of Toxoplasma IgM Commercial Test Kits
Public Health Advisory	7/7/97	Assays for Antibodies to Borrelia burgdorferi; Limitations, Use, and Interpretation for Supporting a Clinical Diagnosis of Lyme Disease
Notice	6/13/97	Radioactivity in Radiation Protection Devices (8/5/97 and 10/16/97 Updates to Notice)
Notice	5/21/97	Steam Re-Sterilization Causes Deterioration of Zirconia Ceramic Heads of Total Hip Prostheses
Notice	4/17/97	Potential Infection Problem With Medical Devices Rented or Leased by Health Care Facilities
Safety Alert	3/24/97	Risks of Devices for Direct Detection of Group B Streptococcal Antigen
Notice	12/16/96	Important Information Relating to Cellulose Acetate Dialyzers
Notice	10/10/96	Dear Manufacturers and Users of Lasers for Refractive Surgery
Public Health Advisory	6/27/96	Potential Risk of Spontaneous Combustion in Large Quantities of Patient-Examination Gloves
Public Health Advisory	12/12/95	Hazards Associated With The Use of Electric Heating Pads
Public Health Advisory	10/16/95	Retinal Photic Injuries From Operating Microscopes During Cataract Surgery
Safety Alert	8/23/95	Entrapment Hazards With Hospital-Bed Side Rails
Notice	7/15/94	Important Information About TMJ Implants
Public Health Advisory	9/30/94	Avoidance of Serious X-Ray-Induced Skin Injuries to Patients During Fluoroscopically Guided Procedures
Safety Alert	4/18/94	Hazards of Precipitation Associated With Parenteral Nutrition
Public Health Advisory	3/1/94	Avoiding Injuries From Rapid Drug or I.V. Fluid Administration Associated With I.V. Pumps And Rate-Controller Devices
Public Health Advisory	2/28/94	Occluded Endotracheal Tubes
Public Health Advisory	12/28/93	Unsafe Electrode Lead Wires and Patient Cables Used With Medical Devices
Safety Alert	9/3/93	Unsafe Patient Lead Wires and Cables
Safety Alert	9/15/93	Hazards of Volume Ventilators and Heated Humidifiers

For copies of documents dated earlier than 1994, contact Dolly Wilson, (mxw@cdrh.fda.gov) or fax 301-594-2968. Please provide your name, mailing address or fax number, and the title of the document you are requesting.

Other Resources

• E-Mail Notification: If you are interested in receiving Safety Alerts, Public Health Advisories, and other FDA safety notices by e-mail when they are released, subscribe to the DEV-ALERT mailing list.
• CDRH Recall Information
  
• Additional FDA Safety Information

Updated October 27, 2004

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