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U.S. Department of Health and Human Services

Class 2 Device Recall HEPFLUSH

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  Class 2 Device Recall HEPFLUSH see related information
Date Initiated by Firm December 19, 2014
Date Posted January 29, 2015
Recall Status1 Terminated 3 on January 26, 2016
Recall Number Z-1032-2015
Recall Event ID 70050
510(K)Number K092938  
Product Classification Heparin, vascular access flush - Product Code NZW
Product HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
Code Information Lot 6005501, Exp. Date 1/2016
Recalling Firm/
Fresenius Kabi USA, LLC
3 Corporate Dr
Lake Zurich IL 60047-8930
Manufacturer Reason
for Recall
The lot failed pH specification.
FDA Determined
Cause 2
Component design/selection
Action Fresenius sent an URGENT DRUG RECALL Letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Examine their stock immediately to determine if they have any product from the affected lot. If the consignee is a distributor, immediately notify your customers that have been shipped or may have been shipped this product/lot of this recall and direct them to discontinue distributing or dispensing the affected lot. Please have them prepare to return the product to Fresenius Kabi as instructed in the Urgent Product Recall Response Form. Your customers may retrieve the recall letter and response form at http://www.fresenius-kabi.us /products/pharmaceutical-products/product-updates.html. 2. If you have the affected lot available, immediately discontinue distributing or dispensing the lot, and return all units to Fresenius Kabi ,via FedEx Ground, using the enclosed return goods label and packing slip. A FedEx Ground label can be obtained by checking the box and noting your mailing address on the enclosed Urgent Product Recall Response Form. It will be mailed to the consignee upon receiving the request. A credit memo will be issued covering the quantity of the return to Fresenius Kabi. 3. PLEASE COMPLETE THE ENCLOSED "URGENT PRODUCT RECALL RESPONSE FORM" AND SEND IT BACK TO US IMMEDIATELY VIA EMAIL OR FAX AT 1-708-649-8630. Use the following contact phone numbers as appropriate. Hours of operation: Monday through Friday 8:00 am to 5:00 pm CST: QA Department: (866) 716-2459 for information on how to return product; Vigilance & Medical Affairs: 1(800) 551-7176 for clinical/technical information/Adverse Events (ADE's) reporting.
Quantity in Commerce Domestic: 69,725
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 = NZW and Original Applicant = APP PHARMACEUTICALS, LLC