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 AquaA

  • 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 AquaAsee related information
Date Initiated by FirmMay 16, 2024
Date PostedJune 13, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2141-2024
Recall Event ID 94676
510(K)NumberK143617 
Product Classification Subsystem, water purification - Product Code FIP
ProductUS AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
Code Information UDI-DI: 04251285200357 Serial Numbers: 2AAV0003 2AAV0029 2AAV0037 3AAV0087
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 920
Waltham MA 02451-1521
For Additional Information ContactFresenius Medical Care Technical Service
800-227-2572 Ext. 4
Manufacturer Reason
for Recall		Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
FDA Determined
Cause 2		Process control
ActionFresenius Medical issued Urgent Medical Device Correction letter on 5-16-2024. Letter states reason for recall, health risk and action to take: A Fresenius Medical Care Water Systems Service Specialist will be contacting you to schedule an evaluation of your Water Treatment system and provide feedback on your system. For questions or concerns, please contact Fresenius Medical Care Technical Services at 800-227-2572, OPTION 4. " Please provide this letter to your Biomedical Technician " Report any complaints or adverse events to product.complaints@fmc-na.com or FDA MedWatchathttps://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting. " Provide this Customer Notice to all those who need to be aware within your organization. " Complete and return the attached reply form.
Quantity in Commerce4 units
DistributionUS Nationwide distribution in the states of AL, IN, AK, WI.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FIP
-
-