LimFlow Vector devices recalled over an incorrect expiration date
LimFlow, Inc. is recalling 33 units of the LimFlow Vector, model VT-US-23, over an incorrect expiration date.
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 under the minor labeling criterion: the record cites an incorrect expiration date with no stated consequence or reported harm.
Plain-English summary
The LimFlow Vector, model/catalog number VT-US-23, is being recalled by LimFlow, Inc.
The reason given in the enforcement record is an incorrect expiration date.
The record lists 33 units under model VT-US-23, lot 82321838, GTIN 00850041730134, US product code MGZ. Distribution was nationwide in the United States across the states listed in the enforcement record. The FDA has classified the action as Class II.
The record cites a printed date error and states no further consequence or reported injuries. Facilities should quarantine the affected lot and follow LimFlow's instructions.
The recalled product
- Product
- Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
- Manufacturer
- LimFlow, Inc.
- Category
- Medical Device — Vascular device
- Affected units
- 33
Distribution
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