Recall Z-1319-2014— Merit Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2014-03-13, terminated 2014-07-07. It names one FDA 510(k) clearance: K883718. 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.. Reason: The products are labeled as sterile but were not sterilized..
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-13
- Terminated
- 2014-07-07
- Firm location
- South Jordan, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.