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 3 Device Recall Granuflo Dry Acid Concentrate

  • 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 3 Device Recall Granuflo Dry Acid Concentrate see related information
Date Initiated by Firm October 09, 2018
Create Date November 29, 2018
Recall Status1 Terminated 3 on August 05, 2021
Recall Number Z-0516-2019
Recall Event ID 81451
510(K)Number K030497  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL
Catalog Number: OFD2201-3B for hemodialysis
Code Information Lot code:18ETGF005
Recalling Firm/
Manufacturer		 Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
Manufacturer Reason
for Recall		 Discolored powder has confirmed the presence of a foreign substance
FDA Determined
Cause 2		 Under Investigation by firm
Action Fresenius issued on 10/9/18 via Certified Mail An Urgent Medical Device Recall Customer Notification to affected consignees asking the consignees to check their stock immediately. If they have any listed GranuFlo Dry Acid Concentrate lot. numbers discontinue use immediately and place the product in a secure, segregated area. The Urgent Medical Device Recall Customer Notification ask for the return of the affected lots and to contact Stericycle on instructions how to return the recalled lots. Contact Stericycle at 1-888-671-8851 for instructions on how to return the recalled product. This is EVENT# 10021.
Quantity in Commerce 4752
Distribution Distribution US nationwide and Mexico
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 = KPO and Original Applicant = FRESENIUS MEDICAL CARE
-
-