Risk Alert - Products

TMLT Risk Alerts address problems discovered with medicines and other health related products. Check it often for new information. Any articles, forms, checklists, guidelines, and materials on this site are for generalized information only, and should not be used or referred to as primary legal sources nor construed as establishing medical standards of care. The TMLT insurance policy contains specific language concerning the prescription of medications which excludes coverage for: "Any use, administration or prescription of any drug, medical device, implant or pharmaceutical not approved by the U. S. Food and Drug Administration for treatment of human beings or for which such insured is not licensed to use, administer or prescribe."

Click on the product names below to view the full Risk Alert.

Cubicin (daptomycin for injection)
Audience: Infectious disease healthcare professionals, hospital risk managers, and nursing service managers

Medtronic AneuRx Stent Graft System
Audience: Vascular surgery healthcare professionals, hospital surgical service managers

Silicone gel-filled breast implants
Audience: Plastic Surgeons

Medtronic SynchroMed EL Implantable Infusion Pump
Audience: Pain management specialists, risk managers, other healthcare professionals, patients

Biliary stents
Surgeons, Cardiologists, Cardio-Vascular Surgeons

Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters
Audience: Cardiovascular healthcare professionals, hospital risk managers

Heparin Lock Flush Solution (Pre-Filled 5 ml in 12 ml Syringes)
Audience: Hospital and nursing home administrators, hospital risk managers, pharmacists, other healthcare professionals, consumers

Bayer Diabetes Care Contour Test Strips (TS)
Audience: Endocrinologists, healthcare professionals, diabetic patients, and pharmacies

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol and generics)
Audience: Neurologists, psychiatrists, other healthcare professionals, consumers

Radio Frequency Ablation Devices
Audience: Thoracic Surgeons, hospital administrators, other healthcare professionals

Thoratec Implantable Ventricular Assist Devices
Audience: Cardiologists, hospital risk managers, patients

Welch Allyn AED 10 Automatic External Defibrillators
Audience: Emergency services personnel, risk managers, and consumers

These documents are available in PDF format, and you will need Acrobat Reader to view them. Download the Acrobat Reader by clicking on the Acrobat icon. A new window will open in your browser, and you will be led through a three-step download process. Once you have Acrobat Reader, you can click on these links and view the publications.

Newswatch

Unretrieved Device Fragments
Audience: Radiologists, surgeons, hospital risk managers, other healthcare professionals