Hemodialysis systems recalled because a screw may loosen or fall out
Nipro Medical is recalling Surdial DX Hemodialysis Systems because a screw may loosen or fall out of the system.
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: Scored 2 because the record cites a loosening screw with no stated consequence or reported harm.
Plain-English summary
The Surdial DX Hemodialysis System, REF MC+SDX01, prescription only, is being recalled by Nipro Medical Corporation.
The reason given in the enforcement record is that a screw may loosen or fall out of the hemodialysis system.
The record does not state a quantity. Affected units carry UDI 00383790008815 with serial numbers listed in the enforcement record, including 20EW0001, 20EW0002, 20EW0005 and 20EW0006. Distribution was nationwide in the United States, in Alabama, Arkansas, California, Florida, Georgia, Illinois, Iowa, Michigan, Minnesota, Mississippi, New Jersey, New York, North Carolina, North Dakota, Ohio, Oregon and Pennsylvania among other states. The FDA has classified the action as Class II.
The record describes a loosening fastener and states no further consequence or reported injuries. Facilities should follow Nipro's instructions.
The recalled product
- Product
- Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
- Manufacturer
- Nipro Medical Corporation
- Category
- Medical Device — Dialysis system
Distribution
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