The Recall Desk
HighFDA (Devices)·Z-0635-2017·Announced 2016-11-30

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.

What this means for you

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
Hazard
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

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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.

See all 5 products in this recall →

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