The Recall Desk
HighFDA (Devices)·Z-0633-2017·Announced 2016-11-30

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.

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.

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
Hazard
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

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 →

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

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Same hazard · sterility compromise

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