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.
What this means for you
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
- formulation-defect
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
Distributed nationwide across the United States.
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