Excelsior Medical Corp 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Excelsior Medical Corp
Lot Codes / Batch Numbers
Product codes: E0100 20, 100 92-240 and 100 92-30: External Lot #/Expiration Date 01-003-DS 9/1/2008, 34-021-BB 10/1/2008, 46-060-9D 10/1/2008, 34-023-BB 10/1/2008, 08-024-DS 5/1/2009, 09-005-DS 7/1/2009, 58-012-9D 10/1/2009, 58-025-9D 10/1/2009, 58-042-9D 10/1/2009, 59-007-9D 11/1/2009, 11-013-DS 7/1/2009, 12-011-DS 7/1/2009, 60-015-9D 12/1/2009, 60-020-9D 12/1/2009, 62-024-9D 2/1/2010, 62-025-9D 2/1/2010, 63-032-9D 3/1/2010, 64-027-9D 4/1/2010, 65-008-9D 5/1/2010, 19-002-DS 4/1/2010, 19-015-DS 5/1/2010, 66-029-9D 6/1/2010, 20-008-DS 5/1/2010, 67-036-9D 7/1/2010, 69-021-9D 9/1/2010, 69-036-9D 9/1/2010, 70-018-9D 10/1/2010, 23-014-DS 8/1/2010 and 24-019-DS 8/1/2010.
Products Sold
Product codes: E0100 20, 100 92-240 and 100 92-30: External Lot #/Expiration Date 01-003-DS 9/1/2008, 34-021-BB 10/1/2008, 46-060-9D 10/1/2008, 34-023-BB 10/1/2008, 08-024-DS 5/1/2009, 09-005-DS 7/1/2009, 58-012-9D 10/1/2009, 58-025-9D 10/1/2009, 58-042-9D 10/1/2009, 59-007-9D 11/1/2009, 11-013-DS 7/1/2009, 12-011-DS 7/1/2009, 60-015-9D 12/1/2009, 60-020-9D 12/1/2009, 62-024-9D 2/1/2010, 62-025-9D 2/1/2010, 63-032-9D 3/1/2010, 64-027-9D 4/1/2010, 65-008-9D 5/1/2010, 19-002-DS 4/1/2010, 19-015-DS 5/1/2010, 66-029-9D 6/1/2010, 20-008-DS 5/1/2010, 67-036-9D 7/1/2010, 69-021-9D 9/1/2010, 69-036-9D 9/1/2010, 70-018-9D 10/1/2010, 23-014-DS 8/1/2010 and 24-019-DS 8/1/2010.
Excelsior Medical Corp is recalling Sterile Field Saline Flush; 0.9% Sodium Chloride Injection, USP; Rx Only; Single Use. Excelsior Medi due to Sterility Issue: There is the possibility that the affected lots have pouches that were not sealed properly and could potentially compromise the exte. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026