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Recall Observatory FDA recall evidence

Device product

HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.

Z-1479-2021

March 31, 2021

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 87647
Status
Terminated
Classification
Class II
Quantity
8150 units
Official record key
device-enforcement:Z-1479-2021

Official wording

Reason: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.

Code information: a. Model Number MX496HP, Lot Numbers: 3952480, 3974771 b. Model Number MX497HP, Lot Numbers: 3949391, 3971003

Distribution pattern: Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.