FDA-Device2024-01-24Class II
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
Smiths Medical Asd Inc
Hazard
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
Affected count
31,685 total
Manufactured in
6250 Shier Rings Rd, N/A, Dublin, OH, United States
Products
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0740-2024Don't want to check this manually?
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