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Smiths Medical ASD Inc. recalls Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only
Recalled December 5, 2018 · FDA recall Z-0512-2019 · Smiths Medical ASD
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 · FDA Class II
Units
2,425 devices
Sold at
The potentially affected products were shipped to customers in the US, Canada, and Mexico.
Description
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
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.
Manufacturer(s)
Smiths Medical ASD Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →