Stradis Healthcare recalls Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile

Recall date

December 15, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0931-2023

FDA classification

Class II

Brand / firm

Stradis Healthcare

Sold / distributed

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

Why it was recalled

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile