FDA-Device2023-01-18Class II
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
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
1,175 units
Manufactured in
3600 Burwood Dr, Waukegan, IL, United States
Products
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0945-2023Don't want to check this manually?
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