| | Class 2 Device Recall GRANUFLO |  |
| Date Initiated by Firm | July 14, 2026 |
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| Date Posted | September 03, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3091-2026 |
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| Recall Event ID |
99543 |
| 510(K)Number | K192209 |
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| Product Classification |
Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
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| Product | GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis |
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| Code Information |
1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009;
2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018. |
| FEI Number |
3001451489
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Recalling Firm/
Manufacturer |
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St Bld 920
Waltham MA 02451-1521
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| For Additional Information Contact | Fresenius Medical Care Customer Service
800-323-5188 |
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Manufacturer Reason
for Recall | Complaints of blue-green discoloration in product |
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FDA Determined
Cause 2 | Material/Component Contamination |
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| Action | Fresenius Medical Care issued an URGENT MEDICAL DEVICE RECALL to its consignees on 7/15/2026 via USPS first class mail. The notice explained the issue, potential risk and requested the following action:
"1. Identify if you have any affected product lots on hand.
2. IMMEDIATELY segregate and discontinue use of affected lots.
3. Contact FMCRTG (1-833-203-5448) between 8:00 AM 8:00 PM Eastern daily, for return of affected lots and replacement of your stock.
4. Complete and return the attached REPLY FORM."
For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309. |
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| Quantity in Commerce | 27,216 cs; 2,316 ea |
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| Distribution | Worldwide distribution - US Nationwide and the country of Mexico. |
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| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = KPO
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