Dialysate Concentrate for Hemodialysis Recalled for Out-of-Specification Formulation
Medivators, Inc. recalls 1,381 cases of dialysate concentrate due to a manufacturing anomaly that may result in out-of-specification formulation. Affected lots may not function properly in hemodialysis treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a hemodialysis product with a potential manufacturing defect. The source text does not report any illnesses, injuries, or hospitalizations. Per the rubric, when the hazard is theoretical and no illnesses or injuries have been reported, the score is at most 3.
Plain-English summary
Medivators, Inc. is recalling 1,381 cases of Dialysate Concentrate for Hemodialysis, Lot 489224. Dialysate concentrate is used with bicarbonate in hemodialysis machines to filter waste from the blood of patients with kidney disease.
The lot may have experienced an anomaly during the manufacturing process that could result in an out-of-specification concentrate formulation. Out-of-specification dialysate may not function properly and could affect hemodialysis treatment effectiveness.
The affected product was distributed nationwide to healthcare facilities in Iowa, Illinois, Minnesota, North Dakota, New York, Ohio, South Dakota, and Wisconsin.
Patients and healthcare providers should discontinue use of this product lot and contact Medivators, Inc. for guidance on replacement product.
The recalled product
- Product
- Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
- Manufacturer
- Medivators, Inc.
- Category
- Medical Device — Hemodialysis
- Hazard
- Affected units
- 1,381
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 489224
Distribution
Related recalls
Same manufacturer · Medivators, Inc.
See all →- HighMedivators Recalls Endo Smartcap Endoscope Tubing Due to Manufacturing Anomaly
FDA (Devices) · 2020-04-29
- HighMedivators Recalls Endo SmartCap Tubing Due to Manufacturing Anomaly
FDA (Devices) · 2020-04-29
- ModerateMedivators Recalls Endo SmartCap Tubing Due to Manufacturing Anomaly
FDA (Devices) · 2020-04-29
- HighMedivators Recalls Endo SmartCap Tubing Due to Manufacturing Anomaly
FDA (Devices) · 2020-04-29
- HighMedivators Recalls Endo Smartcap Endoscope Tubing Due to Manufacturing Anomaly
FDA (Devices) · 2020-04-29
Same hazard · formulation defect
See all →- HighDapsone Topical Gel Recalled Due to Crystallization Defect
FDA (Drugs) · 2025-01-08
- HighSunitinib Malate Capsules Recalled Due to Excess Moisture Content
FDA (Drugs) · 2023-07-19
- HighPrescription Drug Recall: Extended Phenytoin Sodium Dissolution Failure
FDA (Drugs) · 2023-06-21
- ModerateTadalafil Tablets Recalled for Incorrect Product Formulation
FDA (Drugs) · 2021-11-17
Similar recalls
- ModerateRockwell Medical Recalls DriSate Hemodialysis Acid Concentrate Due to Contamination
FDA (Devices) · 2018-05-23
- SevereFresenius NaturaLyte Liquid Bicarbonate Concentrate Recalled for Bacterial Contamination
FDA (Devices) · 2015-07-01
- HighFresenius Naturalyte Liquid Acid Concentrate Recall for Conductivity Deviation
FDA (Devices) · 2021-01-20
- HighDialysis concentrate 100425 recalled because safety and efficacy cannot be assured
FDA (Devices) · 2025-12-31
- HighFresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels
FDA (Devices) · 2021-01-20
- HighDialysis concentrate 100325 recalled because safety and efficacy cannot be assured
FDA (Devices) · 2025-12-31