Date Initiated by Firm |
October 09, 2018 |
Create Date |
November 29, 2018 |
Recall Status1 |
Terminated 3 on August 05, 2021 |
Recall Number |
Z-0517-2019 |
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 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis |
Code Information |
Lot code: 18ETGF010 18HTGF002 18HTGF003 18HTGF007 18HTGF011 18HTGF013 18HTGF016 18JTGF005 18JTGF010 18JTGF012 18KTGF001 18KTGF011 |
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 |
92225 |
Distribution |
Distribution US nationwide and Mexico |
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 = KPO and Original Applicant = FRESENIUS MEDICAL CARE
|