FDA-Device2023-01-18Class II
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
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
920 units
Manufactured in
3600 Burwood Dr, Waukegan, IL, United States
Products
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0931-2023Don't want to check this manually?
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