Date Initiated by Firm |
May 24, 2013 |
Date Posted |
June 08, 2013 |
Recall Status1 |
Terminated 3 on August 01, 2016 |
Recall Number |
Z-1523-2013 |
Recall Event ID |
65296 |
510(K)Number |
K111702
|
Product Classification |
Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
|
Product |
AMICUS Exchange Kit;
Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
|
Code Information |
Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014 |
Recalling Firm/ Manufacturer |
Fenwal Inc 3 Corporate Dr Ste 300 Lake Zurich IL 60047-8930
|
For Additional Information Contact |
Mr. John Miller 847-550-2300
|
Manufacturer Reason for Recall |
Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus
Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not include the written description for the s
|
FDA Determined Cause 2 |
Process change control |
Action |
Fenwal sent an Urgent Product Recall letter dated May 24, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately check inventory, discontinue the use of this prod.uct, return the affected product to Fenwal, and complete and return the attached reply form. For questions call 1-800-333-6925. |
Quantity in Commerce |
19 Cases (114 Units) |
Distribution |
USA 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.
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510(K) Database |
510(K)s with Product Code = LKN and Original Applicant = FENWAL, INC.
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