Device 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.
Z-1319-2014
Product summary
- Event
- Event 67844
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80
- Official record key
device-enforcement:Z-1319-2014
Official wording
Reason: The products are labeled as sterile but were not sterilized.
Code information: Lot Number H591335
Distribution pattern: Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
Derived failure modes
-
Unknown
The products are labeled as sterile but were not sterilized.