PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 9, 2014 Initiated: March 13, 2014 #Z-1319-2014

Product Description

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.

Reason for Recall

The products are labeled as sterile but were not sterilized.

Details

Units Affected
80
Distribution
Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
Location
South Jordan, UT

Frequently Asked Questions

What product was recalled?
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.. Recalled by Merit Medical Systems, Inc.. Units affected: 80.
Why was this product recalled?
The products are labeled as sterile but were not sterilized.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 9, 2014. Severity: Moderate. Recall number: Z-1319-2014.