Merit Medical Recalls Custom Sheath Introducer Kits Due to Labeling Error
Merit Medical Systems is recalling 15 Custom Sheath Introducer Kits because they were incorrectly labeled and contained the wrong sheath assembly.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device where the source text explicitly states potential injuries (vasoconstriction, hemorrhage, embolism) but does not report any actual illnesses or injuries, fitting the 'High' severity criteria.
Plain-English summary
Merit Medical Systems, Inc. is recalling 15 units of the Custom Sheath Introducer Kit (REF K21-00031). The recall is due to a manufacturing issue where the product packages were incorrectly labeled with the wrong sheath size and included the incorrect sheath assembly.
The affected products were distributed nationwide in the state of Michigan. The specific lot number is H1583914, and the UDI is 00884450426357.
The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism. Consumers and healthcare providers should stop using these kits and contact Merit Medical Systems for instructions on how to return the product.
The recalled product
- Product
- Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Vascular Access
- Affected units
- 15
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 (3)
- Catalog Number: K21-00031
- Lot Number: H1583914
- UDI: 00884450426357
Distribution
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