Date Initiated by Firm |
May 14, 2010 |
Date Posted |
July 01, 2010 |
Recall Status1 |
Terminated 3 on September 13, 2011 |
Recall Number |
Z-1951-2010 |
Recall Event ID |
55771 |
510(K)Number |
K002277
|
Product Classification |
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
|
Product |
Optiflux¿ F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404.
Designed for single use acute and chronic hemodialysis. |
Code Information |
Lot Number: 10AU04011, Exp 01/13. |
Recalling Firm/ Manufacturer |
Fresenius Medical Care North America 920 Winter St Waltham MA 02451-1521
|
For Additional Information Contact |
SAME 800-662-1237
|
Manufacturer Reason for Recall |
Hemodialyzer may leak at the header/end cap
|
FDA Determined Cause 2 |
Process control |
Action |
Fresenius Medical notified customers by telephone script beginning May 14, 2010 and follow up letter advising users to examine inventory for recalled lot, discontinue use and contact Fresenius Customer Care 1-800-325-5188 , ext. 6610 for instructions on how to return the recalled product. |
Quantity in Commerce |
34,152 units |
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 = KDI and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
|