Resource Optimization & Innovation LLC recalls Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used on…

Recall date

May 4, 2020

Source

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

Recall number

Z-2368-2020

FDA classification

Class II

Brand / firm

Resource Optimization & Innovation LLC

Sold / distributed

US Nationwide distribution including in the states of MO, NC.

Why it was recalled

There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

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

What was recalled

Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.