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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 Flushsee related information
Date Initiated by FirmMay 07, 2012
Date PostedJune 05, 2012
Recall Status1 Terminated 3 on September 12, 2013
Recall NumberZ-1707-2012
Recall Event ID 61823
510(K)NumberK061497 
Product Classification Heparin, vascular access flush - Product Code NZW
ProductHeparin 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 ContactMr. 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
ActionExcelsior 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 Commerce34,230,500 units (596 lots)
DistributionWorldwide Distribution-USA (nationwide) and the countries of Brazil, Canada, and Colombia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NZW
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