FDA-Device2018-12-05Class II
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.
Smiths Medical ASD Inc.
Hazard
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
Sold states
The potentially affected products were shipped to customers in the US, Canada, and Mexico.
Affected count
2,425 devices
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0512-2019Don't want to check this manually?
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