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U.S. Department of Health and Human Services

Class 2 Device Recall Heparin Lock Flush

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  Class 2 Device Recall Heparin Lock Flush see related information
Date Initiated by Firm May 07, 2012
Date Posted June 05, 2012
Recall Status1 Terminated 3 on September 12, 2013
Recall Number Z-1707-2012
Recall Event ID 61823
510(K)Number K061497  
Product Classification Heparin, vascular access flush - Product Code NZW
Product Heparin Lock Flush Solution 100 Unit/mL, USP
3 ml, 4 ml, 5mL, 6 ml fill in a 10 ml Flush Syringe ZR
Excelsior Medical Neptune, NJ 07753
(800) 487-4276
Made in USA
NDC 63807060055.

Used to maintain patency of vascular access devices designed for intermittent infusion therapy. Export product for sale in Colombia are used for locking hemodialysis catheters, for heparinization of extracorporeal systems, in hemodialysis, and for peritoneal dialysis.
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Recalling Firm/
Manufacturer		 Excelsior Medical Corp
1933 Heck Ave
Neptune NJ 07753
For Additional Information Contact Mr. John Linfante
732-776-7525
Manufacturer Reason
for Recall		 Some lots of Heparin Lock Flush, USP Syringes (3 mL fill in 10 ml syringe, 4 mL fill in 10 ml syringe, 5 mL fill in 10 ml and 6 ml in 10 ml syringe), failed Anti-Factor IIa assay for potency.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Excelsior Medical sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using the affected product and to complete and return an attached Customer Reply Form via fax to (866) 807-3714. Contact Excelsior Medical Customer Service at (800) 487-4276 for questions regarding this recall. A second letter which included additional lots was sent out on 5/25/2012 with the date of 5/24/2012. A return response form was also included.
Quantity in Commerce 34,230,500 units (596 lots)
Distribution Worldwide Distribution-USA (nationwide) and the countries of Brazil, Canada, and Colombia.
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 = NZW and Original Applicant = EXCELSIOR MEDICAL CORP.
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