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U.S. Department of Health and Human Services

Class 3 Device Recall Granuflo Dry Acid Concentrate

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 Class 3 Device Recall Granuflo Dry Acid Concentratesee related information
Date Initiated by FirmOctober 09, 2018
Create DateNovember 29, 2018
Recall Status1 Terminated 3 on August 05, 2021
Recall NumberZ-0516-2019
Recall Event ID 81451
510(K)NumberK030497 
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
ProductFresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Code Information Lot code:18ETGF005
FEI Number 3001451489
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
ActionFresenius 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 Commerce4752
DistributionDistribution US nationwide and Mexico
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPO
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