Date Initiated by Firm |
July 18, 2014 |
Date Posted |
August 13, 2014 |
Recall Status1 |
Terminated 3 on February 05, 2015 |
Recall Number |
Z-2203-2014 |
Recall Event ID |
68788 |
510(K)Number |
K080519
|
Product Classification |
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
|
Product |
Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box |
Code Information |
Prismaflex M150. Product number 109990. Batch number 12A0304G to 14C2706. Expiry 01/2014 to 03/2016 |
Recalling Firm/ Manufacturer |
Gambro Renal Products, Incorporated 14143 Denver West Pkwy Lakewood CO 80401-3266
|
For Additional Information Contact |
Thomas W. Dielmann 303-232-6800
|
Manufacturer Reason for Recall |
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
|
FDA Determined Cause 2 |
Device Design |
Action |
Gambro sent an Urgent Field Safety Notice dated July 18, 2014 to all end-users. A Customer Reply Form was attached to the notice for customers to complete and return. |
Quantity in Commerce |
401,451 |
Distribution |
Worldwide 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 = GAMBRO RENAL PRODUCTS, INC.
|