Public Health Notifications

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Archive: 2009

Title	Date
FDA Preliminary Public Health Notification*: Serious Complications Associated with Negative Pressure Wound Therapy Systems	11/13/2009
FDA Public Health Notification: Potentially Fatal Errors with GDH-PQQ* Glucose Monitoring Technology	8/13/2009
Public Health Advisory: Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings

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Archive: 2008

Title	Date
FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence	10/20/2008
FDA Public Health Notification: Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status	9/24/2008
FDA Preliminary Public Health Notification: Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning	7/14/2008
FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion	7/1/2008
FDA Public Health Notification: Updated Data on Mortality Associated with the Medtronic AneuRx® Stent Graft System	3/17/2008
FDA Public Health Notification: Denture Cleanser Allergic Reactions and Misuse	2/25/2008
FDA Public Health Notification: Unretrieved Device Fragments	1/15/2008

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Archive: 2007

Title	Date
FDA Public Health Notification: Patient Burns from Electric Dental Handpieces	12/12/2007
FDA Public Health Notification: Deaths reported following Radio Frequency Ablation of Lung Tumors	12/11/07
Public Health Notification from FDA: Vail Products Enclosed Bed Systems	12/4/2007
Public Health Notification from FDA, CDC, EPA and OSHA: Avoiding Hazards with Using Cleaners and Disinfectants on Electronic Medical Equipment	10/31/2007
FDA Public Health Notification: Importance of Vaccination in Cochlear Implant Recipients	10/10/2007
FDA Preliminary Public Health Notification: Repair, Service, or Testing May Not Have Been Performed on Certain Baxter COLLEAGUE and FLO-GARD Infusion Pumps	8/13/2007
Questions and Answers on HoMedics®, Inc. Heating Pads and General Heating Pad Safety	7/25/2007
FDA Preliminary Public Health Notification: Acanthamoeba Keratitis Infections Potentially Related to Complete MoisturePlus Multipurpose Contact Lens Solution Manufactured by Advanced Medical Optics (AMO)	5/31/2007
FDA Preliminary Public Health Notification*: Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Devices Manufactured by Shelhigh, Inc.	5/18/2007
FDA Preliminary Public Health Notification*: Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Devices Manufactured by Shelhigh, Inc. (archived)	4/18/07
FDA Public Health Notification: Unpredictable Events in Medical Equipment due to New Daylight Saving Time Change	3/1/2007
FDA Public Health Notification: Custom Ultrasonics, Inc. Endoscope Washer/Disinfectors	2/27/07
FDA Public Health Notification: Updated Information on Custom Ultrasonics, Inc., Endoscope Washer/Disinfector	7/19/2007
FDA Public Health Notification: Precautions in Using the Reintroduced Vapotherm®> 2000i [Respiratory Gas Humidifier] System	2/1/2007

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Archive: 2006

Title	Date
FDA Public Health Notification: Reprocessing of Reusable Ultrasound Transducer Assemblies Used for Biopsy Procedures	6/22/2006
FDA AND NIOSH Public Health Notification: Oxygen Regulator Fires Resulting from Incorrect Use of CGA 870 Seals	6/19/2006
FDA Public Health Notification: Fungal Keratitis Infections Related to Contact Lens Use	5/31/2006
FDA Preliminary Public Health Notification: Important Safety Recommendations for Baxter's COLLEAGUE Infusion Pumps	4/28/06
FDA AND NIOSH Public Health Notification: Oxygen Regulator Fires Resulting from Incorrect Use of CGA 870 Seals (archived)	4/24/06
Preliminary Public Health Notification - Fungal Keratitis Infections Related to Contact Lens Use (2nd archival)	4/21/06
Preliminary Public Health Notification - Fungal Keratitis Infections Related to Contact Lens Use (1st archival)	4/10/06
FDA Updated Public Health Notification: Gambro Prisma® Continuous Renal Replacement System	2/27/2006
FDA Public Health Notification: Continued Risk of Bacterial Meningitis in Children with Cochlear Implants with a Positioner Beyond Twenty-Four Months Post-Implantation	2/6/2005

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Archive: 2001-2005

Title	Date
Second Update of FDA Preliminary Public Health Notification*: Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators	12/28/05
FDA Preliminary Public Health Notification*: Update of Information about Ralstonia spp. Associated with Vapotherm® Respiratory Gas Administration Device	12/20/05
FDA Public Health Notification: Risk of Electromagnetic Interference with Medical Telemetry Systems Operating in the 460-470 MHz Frequency Bands	11/16/05
FDA Preliminary Public Health Notification*: New Information about Ralstonia spp. Associated with Vapotherm® Respiratory Gas Administration Device	10/27/05
FDA Preliminary Public Health Notification*: Recall of Boston Scientific ENTERYX® Procedure Kits and ENTERYX® Injector Single Packs for Treatment of Gastroesophageal Reflux Disease (GERD)	10/14/05
Update of FDA Preliminary Public Health Notification*: Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators	10/13/05
FDA Preliminary Public Health Notification*: Gambro Prisma® Continuous Renal Replacement System	8/23/05
FDA Public Health Notification: Complications from Metallic Tracheal Stents in Patients with Benign Airway Disorders	7/29/05
FDA Preliminary Public Health Notification*: Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators	7/14/05
FDA Public Health Notification: MRI-Caused Injuries in Patients with Implanted Neurological Stimulators	5/10/05
FDA Preliminary Public Health Notification*: Vail Products Enclosed Bed Systems	3/25/05
FDA Public Health Notification: Paralysis from Absorbable Hemostatic Agent	4/2/04
FDA Public Health Web Notification: Counterfeit Polypropylene Mesh	12/19/03
FDA Public Health Notification: Safety Tips for Preventing Hospital Bed Fires	12/18/03
FDA Public Health Notification: Updated Data on Mortality Associated with Medtronic AVE AneuRx® Stent Graft System	12/17/03
FDA Public Health Web Notification*: Final Update of Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Sirolimus-eluting Coronary Stent	11/25/03
FDA Public Health Web Notification*: Updated Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Sirolimus-eluting Coronary Stent (2nd archival)	11/25/03
FDA Public Health Web Notification*: Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Coronary Stent (1st archival)	10/29/03
FDA Public Health Notification: Diathermy Interactions with Implanted Leads and Implanted Systems with Leads	12/19/02
FDA Public Health Web Notification*: Complications Related to the Use of Bone Cement and Bone Void Fillers in Treating Compression Fractures of the Spine	10/31/02
FDA Public Health Web Notification: Non-Corrective Decorative Contact Lenses Dispensed Without a Prescription	10/23/02
FDA Public Health Web Notification: Human Tissue Processed by Cryolife, Inc.	8/21/02
FDA Public Health Web Notification*: Risk of Bacterial Meningitis in Children with Cochlear Implants	7/24/02
FDA Public Health Notification: PVC Devices Containing the Plasticizer DEHP	7/12/02
FDA Safety Alert: Recall of Ob/Gyn and Surgical Products	3/15/02
FDA Public Health Notification: Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients	11/2/01
FDA Public Health Advisory: Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels	7/20/2001
FDA Public Health Notification: Problems with Endovascular Grafts for Treatment of Abdominal Aortic Aneurysm (AAA)	4/27/2001
FDA Public Health Notification: Lead Exposure from Dental Films Stored in Lead-Lined Table-top Containers	3/13/2001

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Archive: 1996-2000

Title	Date
FDA Public Health Notification: Serious Injuries from Microwave Thermotherapy for Benign Prostatic Hyperplasia	10/11/2000
Potential for Injury from Circumcision Clamps	8/29/2000
FDA Public Health Advisory: Risk of Electromagnetic Interference with Medical Telemetry Systems	7/10/2000
FDA Urgent Information: Recall of Clinipad Sterile Products Used in Prepackaged Procedure Kits and Trays	3/29/2000
Important Information Regarding the Year 2000 Transition	12/30/00
FDA Public Health Notification: Important Information about Y2K and Medical Devices	12/13/99
Complications Related to the Use of Vascular Hemostasis Devices	10/8/99
FDA and CDC Public Health Advisory: Infections from Endoscopes Inadequately Reprocessed by an Automated Endoscope Reprocessing System	9/10/99
FDA Safety Alert: Potential Cross-Contamination Linked to Hemodialysis Treatment	5/11/99
Hypotension and Bedside Leukocyte Reduction Filters	5/4/99
Glass Capillary Tubes: Joint Safety Advisory About Potential Risks	2/22/99
FDA And NIOSH Public Health Advisory: Explosions and Fires in Aluminum Oxygen Regulators	2/4/99
FDA Medical Device Malfunction Advisory	12/29/98
Interaction Between Minute Ventilation Rate-Adaptive Pacemakers and Cardiac Monitoring and Diagnostic Equipment	10/14/98
NIR ON™ Ranger™ w/SOX™ PREMOUNTED STENT SYSTEM	10/8/98
Important Information on Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators	9/28/98
Electrical Hazards Associated With Lead Wires and Cables	8/3/98
FDA Public Health Advisory: Need for CAUTION When Using Vacuum Assisted Delivery Devices	5/21/98
FDA Safety Alert: Warning Regarding the Use of the AbTox Plazlyte™ Sterilization System	4/13/98
FDA Public Health Advisory: Interference Between Digital TV Transmissions and Medical Telemetry Systems	3/20/98
FDA Public Health Notice: Potential Hypersensitivity Reactions To Chlorhexidine-Impregnated Medical Devices	3/13/98
FDA Safety Alert: Supplemental Information Regarding: Failure of Isocam II, Dual-Headed Nuclear Medicine Gamma Camera	3/12/98
FDA Public Health Notice: Failure of Isocam II, Dual-Headed Nuclear Medicine Gamma Camera	2/13/98
Notice about Vacuum Loss in Electronic Resonating Components	8/13/97
FDA Public Health Advisory: Limitations of Toxoplasma IgM Commercial Test Kits	7/25/97
FDA Public Health Advisory: Assays for Antibodies to Borrelia burgdorferi; Limitations, Use, and Interpretation for Supporting a Clinical Diagnosis of Lyme Disease	7/7/97
Update to FDA Public Health Notice Radioactivity in Radiation Protection Devices	6/13/97
Radioactivity in Radiation Protection Devices	6/13/97
Steam Re-Sterilization Causes Deterioration of Zirconia Ceramic Heads of Total Hip Prostheses	5/21/97
Potential Infection Problem With Medical Devices Rented or Leased by Health Care Facilities	4/17/97
FDA Safety Alert: Risks of Devices for Direct Detection of Group B Streptococcal Antigen	3/24/97
Important Information Relating to Cellulose Acetate Dialyzers	12/19/96
FDA Public Health Advisory: Potential Risk of Spontaneous Combustion in Large Quantities of Patient Examination Gloves	6/27/96

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Archive: 1991-1995

Title	Date
FDA/CPSC Public Health Advisory - Hazards Associated With The Use of Electric Heating Pads	12/12/95
Public Health Advisory: Retinal Photic Injuries From Operating Microscopes During Cataract Surgery	10/16/95
Urgent Notice About Recalled Blood Glucose Test Strips	10/11/95
FDA Safety Alert: Entrapment Hazards with Hospital Bed Side Rails	8/23/95
Avoidance of Serious X-Ray-Induced Skin Injuries to Patients During Fluoroscopically-Guided Procedures	9/30/94
Important Information About TMJ Implants	7/15/94
Hazards of Precipitation Associated With Parenteral Nutrition	4/18/94
Avoiding Injuries From Rapid Drug or I.V. Fluid Administration Associated With I.V. Pumps And Rate-Controller Devices	3/1/94
Occluded Endotracheal Tubes	2/28/94
Safety Alert: Laerdal Defibrillators	1/26/94
Public Health Advisory: Unsafe Electrode Lead Wires and Patient Cables Used With Medical Devices	12/28/93
Hazards of Volume Ventilators and Heated Humidifiers	9/15/93
Safety Alert: Unsafe Patient Lead Wires and Cables	9/3/93
Fluoride Contamination of Hemodialysis Water Supply	8/19/93
Hazards of Heated-Wire Breathing Circuits	7/14/93
MRI-Related Death of Patient With Aneurysm Clip	11/25/92
Important Information About Studies on Dialyzer Germicides	10/23/92
Potential Hazards With Restraint Devices	7/15/92
FDA Safety Alert: Caude Equina Syndrome - Use of Catheters.	5/29/92
Aluminum and Other Trace-Element Contamination in Dialysis Facilities	5/20/92
Information on Shiley CC Valve Fractures	4/21/92
Needlestick and Other Risks From Hypodermic Needles on Secondary I.V. Administration Sets - Piggyback and Intermittent I.V.	4/16/92
Anaphylactoid Reactions Associated With ACE Inhibitors and Dialyzer Membranes	3/6/92
Vitek Proplast Temporomandibular Joint Implants	9/1991

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Archive: 1983-1990

Title	Date
Serious Problems With Proplast-Coated TMJ Implant	12/28/90
Hepatitis B Transmission Via Spring-Loaded Lancet Devices	8/28/90
Gas/Air Embolism Associated With Intrauterine Laser Surgery	5/11/90
Important Tips for Apnea Monitor Users	2/16/90
New FDA Recommendations and Results of Contact Lens Study	5/30/89
Sodium Azide Contamination of Hemodialysis Water Supplies	3/15/89
Homemade Saline Solutions for Lenses	1/24/89
Chloramine Contamination of Hemodialysis Water Supplies	2/19/88
FDA Safety Alert - Possibly Contaminated Dura Mater	4/28/87
Danger Involving Apnea Monitors	6/19/85
FDA Safety Alert - Defibrillator Batteries	3/28/85
FDA Alert - Pediatric Cribs	7/2/84
Dialyzer: First-Use Syndrome	11/20/83
FDA Safety Alert - Breathing System Connectors	9/2/83
FDA Safety Alert - Electrically Powered Hospital Beds	6/16/83

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