510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0973-2009

Sterile Field Saline Flush; 0.9% Sodium Chloride Injection, USP; Rx Only; Single Use. Excelsior Medical...

Excelsior Medical LLC / initiated 2009-01-13 / Terminated / root cause: packaging
FDA source (opens on fda.gov)

Excelsior Medical Corp began a recall of 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... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-0973-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Excelsior Medical LLC
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.
Product code
NGT Saline, Vascular Access Flush
Reason for recall
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.
Root cause tag
packaging
FDA root cause
Packaging process control
Action
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.
Quantity in commerce
341,580 units
Distribution
Nationwide Distribution.
Product codes and lots
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.