Date Initiated by Firm |
April 28, 2016 |
Date Posted |
June 14, 2016 |
Recall Status1 |
Terminated 3 on August 08, 2017 |
Recall Number |
Z-1989-2016 |
Recall Event ID |
74045 |
510(K)Number |
K023740
|
Product Classification |
Heparin, vascular access flush - Product Code NZW
|
Product |
Excelsior 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 Contact |
Mr. 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 |
Action |
Excelsior 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 Commerce |
184,500 |
Distribution |
US Nationwide distribution. |
Total Product Life Cycle |
TPLC Device Report
|
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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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