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.
FDA Recall Z-1319-2014 · Posted 2014-04-03
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Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeOBI
Date Initiated2014-03-13
Date Terminated2014-07-07
Product Quantity80
Reason for Recall
The products are labeled as sterile but were not sterilized.
Firm Action
Merit Medical sent an Urgent Product Recall Notice dated March 14, 2014 to all customers and sales representatives via email. The letter identified the affected product, problem and actions to be taken. Customers were provided a Product Retrieval Form, product identification information, instruction to immediately quarantine any devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative to arrange product return and replacement. For questions call 1-801-316-4822.
Root Cause
Release of Material/Component prior to receiving test results
Distribution Pattern
Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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