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Recall Observatory FDA recall evidence

Device product

Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

Z-0512-2019

November 19, 2018

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 81599
Status
Terminated
Classification
Class II
Quantity
2,425 devices
Official record key
device-enforcement:Z-0512-2019

Official wording

Reason: Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924

Code information: Model Number (Lot Number): MX4301L (3538569), MX4331L (3562377, 3546826), MX4331R (3546924)

Distribution pattern: The potentially affected products were shipped to customers in the US, Canada, and Mexico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924