FDA-Device2023-01-18Class II
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Stradis Healthcare
Hazard
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Sold states
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Affected count
80 units
Manufactured in
3600 Burwood Dr, Waukegan, IL, United States
Products
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0944-2023Don't want to check this manually?
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