Date Initiated by Firm |
November 19, 2010 |
Date Posted |
January 10, 2011 |
Recall Status1 |
Terminated 3 on November 03, 2012 |
Recall Number |
Z-0844-2011 |
Recall Event ID |
57293 |
510(K)Number |
K962081
|
Product Classification |
Hemodialysis Blood Tubing Set - Product Code FJK
|
Product |
Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7 |
Code Information |
Lots 09JR01174, 09JR01229, 09NR01139, 10KR01801 |
Recalling Firm/ Manufacturer |
Fresenius Medical Care Holdings, Inc. 920 Winter St Waltham MA 02451-1521
|
For Additional Information Contact |
SAME 800-662-1237
|
Manufacturer Reason for Recall |
Hemodialysis Blood tubing Sets may develop kinking of the arterial line.
|
FDA Determined Cause 2 |
Device Design |
Action |
Fresenius Medical issued recall notification dated 11/19/10, "URGENT RECALL FMCNA Combiset¿ BVM Hemodialysis Blood Tubing Sets (Part Numbers 03-2695-9 and 03-27957)", by certified mail with return receipt. Customers have been instructed to check their stock immediately to determine if they have any affected lots on hand. If customers have the affected lots, they have been instructed to discontinue use immediately and place the product in a secure segregated area for return to Fresenius Medical Care North America. Customers have been instructed to contact Fresenius Medical Care Customer Service Team Representative for instructions on how to return the recalled product. |
Quantity in Commerce |
10, 032 units (418 cases x 24 units) |
Distribution |
Distribution Nationwide and Canada |
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 = FJK and Original Applicant = NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
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