Excelsior Medical Recalls Prefilled Syringes Over Possible Sterility Issues

Excelsior Medical is recalling its 5 ml Fill In 6 cc <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">Prefilled Saline Flush Syringes over a potential loss of sterility, the US Food and Drug Administration (FDA) just announced.

Routine internal testing conducted on this product found that some of these syringes may leak and lose sterility. This recall pertains only to syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. Exposure to syringes with a sterility issue could result in systemic infection, which may lead to serious injury and/or death.

The Excelsior Disposable 5ml Fill In 6 cc Prefilled Saline Flush Syringes are intended for the flushing of venous access devices and Intravenous (IV) tubing.

Consumers with 5 ml Fill In 6 cc Prefilled Saline Flush Syringes manufactured by Excelsior Medical should immediately discontinue using these syringes and return them to the point of purchase.

The FDA has classified this action as a Class I recall, which involves a situation in which there is a reasonable probability that the use or exposure will cause serious adverse health consequences or death.

On September 2, 2010, the company sent an urgent Medical Device Recall Notification to customers of its Excelsior Disposable 5 ml Fill In 6 cc Prefilled Saline Flush Syringes product stating that routine internal testing conducted on this product found that some of these syringes may leak and lose sterility.

All product affected by this recall had passed all release testing including sterility testing.

The affected products are distributed to hospitals and home health care agencies by Excelsior Medical’s network of med-surge, pharmacy and independent medical distributors. This product is available by prescription only and is not sold over the counter. This recall covers certain products (as outlined above) distributed within the United States, Canada and Brazil.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm.

• Download the form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm or call 1-800-332-1088 to request a reporting form. Complete and return the form to the address on the pre-addressed form, or submit it by fax to 1-800-FDA-0178.

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