Date Initiated by Firm | July 18, 2014 |
Date Posted | August 13, 2014 |
Recall Status1 |
Terminated 3 on February 05, 2015 |
Recall Number | Z-2201-2014 |
Recall Event ID |
68788 |
510(K)Number | K041005 |
Product Classification |
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
|
Product | Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box |
Code Information |
Prismaflex M60 set. Product number 106696. Batch number 12A0605 to 14A2011. Expiry 01/2014 to 01/2016 |
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
|