Home / Recalls / Medical Devices
Stradis Healthcare recalls Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Recalled January 18, 2023 · FDA recall Z-0947-2023 · 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
600 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
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Manufacturer(s)
Stradis Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →