Merit Medical Procedure Kits Recalled for Compromised Sterile Barrier
Merit Medical Systems is recalling 53 Procedure Kits due to a compromised sterile barrier. The kits were distributed nationwide to specific states and Japan.
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 compromised sterile barrier, which is a risk-of-harm product defect where injury has not yet been reported, fitting the 'High' severity criteria for medical devices.
Plain-English summary
Merit Medical Systems, Inc. has announced a voluntary field action for 53 units of Merit Medical Procedure Kits, specifically Catalog Numbers K12-04830B and K12-YP030A. The recall is being conducted because the sterile barrier of these kits is compromised, which may affect the sterility of the contents.
The affected lots are H992344 and H996476. Distribution was nationwide to Virginia, Utah, and North Carolina, as well as to a foreign consignee in Japan. The source text notes that there were no Canadian or VA/government/military consignees.
Consumers and healthcare facilities should stop using these specific kits and contact Merit Medical Systems for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 53
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 (1)
- Lot Numbers: H992344 and H996476
Distribution
Part of a larger recall action
This product is one of 5 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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