The Recall Desk
HighFDA (Devices)·Z-0634-2017·Announced 2016-11-30

Merit Medical Recalls Pressure Monitoring Kits Due to Sterile Barrier Compromise

Merit Medical Systems is voluntarily recalling 130 MeriTrans Pressure Monitoring Kits because a compromised sterile barrier may affect product sterility.

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 is classified as FDA Class II and involves a compromised sterile barrier, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Merit Medical Systems, Inc. has announced a voluntary field action for 130 units of the MeriTrans Pressure Monitoring Kit (Catalog Number K11-00232G, Lot Number H996490). The recall is being conducted because the sterile barrier for these kits is compromised, which may affect the sterility of the product.

The affected units were distributed 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 providers should stop using the affected kits and contact Merit Medical Systems for further instructions or a replacement. This action is classified as a Class II recall by the FDA.

The recalled product

Product
Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
130

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: H996490

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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