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Excelsior Medical Recalls 5 ml Fill in 6 cc Prefilled Saline Flush Syringes

Washington, DC: Excelsior Medical Corporation issued the following update regarding their previously disclosed nationwide recall of Excelsior Disposable 5ml fill in 6 cc Prefilled Saline Flush Syringe W/Normal Saline (0.9 % Sodium Chloride). The FDA has classified this action as a Class I recall. A Class I recall is a situation in which there is a reasonable probability that the use or exposure to a violative product will cause serious adverse health consequences or death.

The Excelsior Disposable 5ml fill in 6 cc prefilled saline flush syringes are intended for the flushing of venous access devices and IV tubing.

On September 2, 2010, the company sent an urgent Medical Device Recall Notification to customers of its Excelsior Disposable 5ml fill in 6 cc prefilled saline flush syringe product stating that routine internal testing conducted on this product found that some of these syringes may leak and lose sterility. This recall pertains only to the 5ml fill in 6 cc pre-filled saline flush syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. The product code number can be found in the barcode on each syringe as well as on the carton label. Exposure to syringes with a leaking and sterility issue could result in systemic infection, which may lead to serious injury and/or death. All product affected by this recall had passed all release testing including sterility testing. The company decided to undertake this recall as a precautionary measure.

No other Excelsior Medical pre-filled saline syringe product codes are affected by this recall.

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Published on Oct-15-10


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