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 Clinical Packaging Solutions Item Number 830096005 Recalled by ROi CPS LLC Due to The kit contains a non-sterile needle.

Date: November 4, 2021
Company: ROi CPS 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 ROi CPS LLC directly.

Affected Products

regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.

Quantity: 40 kits

Why Was This Recalled?

The kit contains a non-sterile needle.

Where Was This Sold?

Distribution was made to Missouri. There was no foreign/military/government distribution.

About ROi CPS LLC

ROi CPS LLC has 86 total recalls tracked by RecallDetector.

Related Recalls

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