Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Gambro

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Gambro see related information
Date Initiated by Firm July 18, 2014
Date Posted August 13, 2014
Recall Status1 Terminated 3 on February 05, 2015
Recall Number Z-2198-2014
Recall Event ID 68788
510(K)Number K032431  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
Code Information Prisma M100 set. Product number 104182. Batch number 12A3005 to 14A1703. 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 and Original Applicant = GAMBRO, INC.
-
-