Rockwell Medical Recalls DriSate Hemodialysis Acid Concentrate Due to Contamination
Rockwell Medical is recalling DriSate hemodialysis acid concentrate because a subassembly component contained small amounts of sodium bicarbonate from a prior batch.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a minor contamination issue (small amounts of sodium bicarbonate) without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Rockwell Medical, Inc. is recalling 139 units of DriSate Product Code DR-145. This product consists of acid concentrate powders and liquids indicated for use in acute and chronic hemodialysis. The affected units are identified by Lot 28562-0220171 and were distributed to the state of New York.
The recall was initiated because a subassembly component, specifically a dextrose bag, within the case product contained small amounts of sodium bicarbonate from a prior batch. This contamination occurred during the manufacturing or assembly process.
Consumers and healthcare facilities that have received this product should stop using it and contact Rockwell Medical for instructions on return or disposal. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
- Manufacturer
- Rockwell Medical, Inc
- Hazard
- Affected units
- 139
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 28562-0220171
Distribution
Distributed in 1 state:
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