Sterile Field Saline Flush; 0.9% Sodium Chloride Injection, USP; Rx Only; Single Use. Excelsior Medical, Neptune, NJ. This product is used for the flushing of venous access devices and intravenous tubing.

Sterility Issue: There is the possibility that the affected lots have pouches that were not sealed properly and could potentially compromise the external sterility of the syringes.

An Urgent Medical Device Recall letter (dated January 13, 2009) was sent to consignees via certified mail, with return receipt requested. The letter provided the reason for the recall and instructions to discontinue use and return (or destroy) the recalled product. The letter also instructed customers to complete the enclosed Customer Reply Form and fax (866-360-6211) to Excelsior Medical Corporation. If the affected product is destroyed on site, fax a copy of the certificate of destruction with the completed Customer Reply Form. Arrangements will be made by Excelsior Medical Corporation for the return of recalled product. Please direct questions to Excelsior Medical Customer Service at 800-487-4276.