Merit Medical Procedure Kits Recalled for Compromised Sterile Barrier
Merit Medical Systems is voluntarily recalling specific Procedure Kits due to a compromised sterile barrier, which may affect the sterility of the contents.
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.
Plain-English summary
Merit Medical Systems, Inc. has announced a voluntary field action for various Merit Medical Procedure Kits. The recall is being conducted because the sterile barrier for these kits is compromised. This defect may result in the kits not being sterile as intended.
The specific product identified in the recall notice is the Waste Management Kit, Catalog Number K10-04381AP. The affected lot number is H996569. The quantity involved is 30 units.
These products were distributed nationwide to Virginia, Utah, and North Carolina. Additionally, one foreign consignee in Japan received the product. There were no Canadian or VA/government/military consignees. Users should stop using the affected kits and contact Merit Medical Systems for further instructions.
The recalled product
- Product
- Waste Management Kit. Catalog Number K10-04381AP
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Procedure Kits
- Affected units
- 30
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 Number: H996569
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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