Resource Optimization & Innovation Llc recalls Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments a…

Recall date

August 25, 2015

Source

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

Recall number

Z-0229-2016

FDA classification

Class II

Brand / firm

Resource Optimization & Innovation Llc

Sold / distributed

Product was distributed to one customer in Oklahoma.

Why it was recalled

The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.

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 Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.