The recall includes only the 5ml fill in 6 cc pre-filled saline flush syringes with the following product codes: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. Other Excelsior Medical pre-filled saline syringe product codes are affected by this recall. The product code number is found in the barcode on each syringe as well and on the carton label.
The Excelsior Disposable 5ml fill in 6 cc prefilled saline flush syringes are used to flush out IV tubing and other venous access devices.
The initial recall occurred on September 2, 2010. The company sent a recall notification to customers after routine internal testing discovered that some of the syringes could leak and lose sterility. Exposure to syringes that are not sterile may result in serious injury, including:
Exposure to syringes that are not sterile may result in:
• Systemic infection and illness
• Long-term intravenous antibiotic treatment
• Wrongful death
The affected products are available only by prescription only and were not sold over the counter. The syringes were distributed to hospitals and home health care agencies in the United States, Canada and Brazil.
Companies that manufacture medical devices are responsible for ensuring the safety and effectiveness of their products before marketing them. If you or a loved one suffered infection or other injury from an Excelsior Disposable 5ml fill in 6 cc Prefilled Saline Flush Syringe W/Normal Saline (0.9 % Sodium Chloride) or any other other contaminated medical device, you may be entitled to financial compensation.
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