The Recall Desk
HighFDA (Devices)·Z-1319-2014·Announced 2014-04-09

Merit Medical Pressure Monitoring Tubing Recalled for Sterilization Failure

Merit Medical Systems is recalling 80 units of Pressure Monitoring Tubing PM6006 because the products were labeled as sterile but were not sterilized.

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 risk-of-harm product where the lack of sterilization poses a significant infection risk, but the source text does not report any specific illnesses or injuries, fitting the High severity criteria.

Plain-English summary

Merit Medical Systems, Inc. is recalling 80 units of Pressure Monitoring Tubing, model PM6006, Lot Number H591335. These medical devices are used between the manifold and transducer to transmit the fluid pressure of the patient to the pressure transducer.

The recall was initiated because the products are labeled as sterile but were not sterilized. The affected units were distributed worldwide, including nationwide in the United States (specifically the state of Wisconsin) and in the countries of Thailand and Hong Kong.

Consumers and healthcare facilities should stop using the affected tubing and contact Merit Medical Systems for further instructions or a replacement.

The recalled product

Product
Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer.
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Pressure Monitoring Tubing
Hazard
Affected units
80

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 H591335

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

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Same hazard · infection risk

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