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U.S. Department of Health and Human Services

Class 2 Device Recall STERILE FIELD SALINE FLUSH

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  Class 2 Device Recall STERILE FIELD SALINE FLUSH see related information
Date Initiated by Firm January 13, 2009
Date Posted February 06, 2009
Recall Status1 Terminated 3 on August 06, 2009
Recall Number Z-0973-2009
Recall Event ID 50848
510(K)Number K053120  
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code NGT
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.
Code Information 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. 
Recalling Firm/
Manufacturer		 Excelsior Medical Corp
1933 Heck Ave
Neptune NJ 07753
For Additional Information Contact Lohn Linfonte
732-643-6088
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NGT and Original Applicant = EXCELSIOR MEDICAL CORP.
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