Health Risks Associated with Medical Products


The FDA has recently announced the following health risks associated with medical products:

  • Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall - May Not Properly Delay an Infusion.  Infusion start times earlier or later than intended could result in serious injury or death.
  • Maquet Datascope Intra-Aortic Balloon Pumps: Class I Recall - Failure of Fan Assembly.  Failure may cause pump to shut down without alarm, and result in heart failure, decreased blood flow to the heart, and/or decreased blood flow to the body and brain.
  • Baxter ABACUS TPN Calculation Software: Class I Recall - Software Errors May Cause Toxic/Overdose Symptoms.  ABACUS Total Parenteral Nutrition (TPN) Calculation Software is a computer program used by pharmacists to calculate or order TPN formulas, which are used to meet the nutritional needs of patients who cannot eat or drink by mouth.
  • Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs: Class I Recall - Prongs May Detach from Nasal Tubing and Interrupt Therapy.
  • NaturaLyte Liquid Bicarbonate Concentrate: Recall – potential health risk due to bacteria levels in affected lots.
  • Male Sexual Enhancement Products: Immediate Public Notification: Undeclared Drug Ingredients.  Risk of interaction with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.

If you or someone you love suffers a serious injury from any defective product, whether it’s on this list or not, remember to call Wallace & Graham at 704-633-5244 or 800-849-5291 for a free consultation.

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