Companies that manufacture medical devices are responsible for ensuring the safety and effectiveness of their products before marketing them. When companies claim a product is sterile, they are responsible for ensuring that the product is sterile and safe for use as directed. Most companies do their job responsibly and routinely test their products for contamination. Unfortunately, some companies are negligent and this negligence leads to recalls of contaminated medical devices.
Here are some examples of recent medical device contamination:
• Stryker CMF Custom Cranial Implants – The product was recalled because sterility could not be guaranteed after multiple FDA safety violations were found in the manufacturing facility.
• Excelsior Saline Syringes – A recall was issued because some syringes may leak and lose sterility.
• Heparin Syringes – These syringes were found to be contaminated with with Serratia marcescens, a bacteria found in soil that can cause serious infection
• Nellcor Puritan Bennett CapnoProbes – The probes which are used for measuring carbon dioxide in the blood were contaminated with the infectious bacteria Burkholderia cepaci and other opportunistic pathogens.
• Hylenex Baby Rehydration Fluids – This pediatric rehydration formula was recalled after 3,200 vials were found to be contaminated with glass shards.
• HYDRAGLIDE™ Brand Heparin-Coated Thoracic Drainage Catheters – The heparin coating the catheters was found to be contaminated with oversulfated chondroitin sulfate which can affect blood pressure and heart rate.
Contaminated medical devices can lead to:
• Wound infection
• Long-term neurological problems
• Long-term intravenous antibiotic treatment
• Wrongful death
Have You Or A Loved One Been Injured By A Defective Medical Device?
If you or a loved one has been injured by a defective medical device you need to speak with an experienced defective medical device attorney as soon as possible. Please contact us online or call our Kansas City office directly at 816.471.5111 to schedule your free consultation.