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.
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 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.
- 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
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.
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