Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Regard Custom Surgical Pack Recalled by Resource Optimization & Innovation Llc Due to The kits contain pressure monitoring kits or sets...

Date: August 25, 2015
Company: Resource Optimization & Innovation Llc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Resource Optimization & Innovation Llc directly.

Affected Products

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.

Quantity: 255 packs

Why Was This 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.

Where Was This Sold?

Product was distributed to one customer in Oklahoma.

About Resource Optimization & Innovation Llc

Resource Optimization & Innovation Llc has 224 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report