Merit Medical Recalls Mixed Hydrophilic Guide Wire Lots
Merit Medical Systems is recalling 173 units of Laureate Hydrophilic Guide Wire due to a labeling discrepancy where the product was mixed with a different lot.
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, which typically corresponds to a moderate severity score. The hazard involves a labeling discrepancy and product mix-up rather than a direct contamination or structural defect causing immediate harm.
Plain-English summary
Merit Medical Systems, Inc. is recalling 173 units of the Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX. The specific product is a straight tip, stiff shaft guide wire measuring 0.035 inches (0.89mm) in diameter and 260 cm (102 inches) in length. The affected lot is identified as Lot No. K556399, with an expiration date of October 2016.
The recall was initiated due to a discrepancy between the carton and unit labeling. The source text indicates that this lot was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, Catalog No. LWSTDA35260EX. The mixed lot features an angled tip, a standard shaft, and Chinese unit labeling, which differs from the recalled product's straight tip and stiff shaft specifications.
The affected units were distributed worldwide, specifically in the USA nationwide and in China. The source notes that there were no military, government, or VA consignees. Consumers and healthcare providers should verify the catalog number and lot number of their guide wires against the recalled details and contact the manufacturer for further instructions.
The recalled product
- Product
- Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 173
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 (2)
- Lot No. K556399
- Expires 2016-10
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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