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 labeled as "LAP - FLOL Recalled by ROi Consolidated Service Center (CSC) Due to Resource Optimization & Innovation (ROi) has received a...

Date: March 21, 2019
Company: ROi Consolidated Service Center (CSC)
Status: Ongoing
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 Consolidated Service Center (CSC) directly.

Affected Products

Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

Quantity: 261 packs

Why Was This Recalled?

Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

Where Was This Sold?

This product was distributed to 2 states: LA, MO

Affected (2 states)Not affected

About ROi Consolidated Service Center (CSC)

ROi Consolidated Service Center (CSC) has 2 total recalls tracked by RecallDetector.

Related Recalls

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