Merit Medical Recalls Hydrophilic Guide Wires Due to Labeling Discrepancy
Merit Medical Systems is voluntarily recalling specific lots of Laureate Hydrophilic Guide Wires due to a discrepancy between carton and unit labeling.
What this means for you
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 involves a labeling discrepancy and lot mixing without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Merit Medical Systems, Inc. is voluntarily conducting a recall of Merit Laureate Hydrophilic Guide Wires. The recall addresses a discrepancy between the carton and unit labeling for specific catalog numbers and lot numbers.
The source text identifies Lot No. K556399 (173 units) of catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft, as being partially mixed with another lot. The structured product information also lists Lot No. K556402 of catalog number LWSTDA35260EX, which has an angled tip and a standard shaft, with a quantity of 186 units. The distribution pattern is listed as worldwide, specifically USA Nationwide and China.
No illnesses or injuries are reported in the source text. The recall is driven by the labeling discrepancy and lot mixing. Consumers and healthcare providers should stop using the affected devices and contact Merit Medical Systems for further instructions.
The recalled product
- Product
- Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- Affected units
- 186
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. K556402
- 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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