Home / Recalls / Medical Devices
Stradis Healthcare recalls Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Recalled January 18, 2023 · FDA recall Z-0931-2023 · 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. · FDA Class II
Units
920 units
Sold at
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Description
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Product
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Manufacturer(s)
Stradis Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →