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U.S. Department of Health and Human Services

Class 2 Device Recall Excelsior Medical Inc.

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 Class 2 Device Recall Excelsior Medical Inc.see related information
Date Initiated by FirmApril 28, 2016
Date PostedJune 14, 2016
Recall Status1 Terminated 3 on August 08, 2017
Recall NumberZ-1989-2016
Recall Event ID 74045
510(K)NumberK023740 
Product Classification Heparin, vascular access flush - Product Code NZW
ProductExcelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.
Code Information Product Code, Lot number, Expiration date.  513604 3123326 7/1/2016 E0500-55 3123349 7/1/2016 513602 3126577 8/1/2017 
Recalling Firm/
Manufacturer		 Excelsior Medical Corp
1933 Heck Ave
Neptune NJ 07753-4428
For Additional Information ContactMr. John Linfante
732-643-6088
Manufacturer Reason
for Recall		Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionExcelsior Medical Inc. sent a recall letter on 4/29/2016 via certified mail. Customers are instructed to discontinue using the product subject to this recall. Customers are requested to complete the customer reply form and fax it (866) 807-3714, so arrangements can be made to return the product to Excelsior.
Quantity in Commerce184,500
DistributionUS Nationwide distribution.
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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