# FDA recall Z-2221-2019

> **ROi Consolidated Service Center (CSC)** · Class II · device recall initiated 2019-03-21.

## Product

Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" 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.

## Reason for recall

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.

## Distribution

Distributed to LA and MO

## Key facts

- **Recall number:** Z-2221-2019
- **Recalling firm:** ROi Consolidated Service Center (CSC)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-03-21
- **Report date:** 2019-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Springfield, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2221-2019

## Citation

> AI Analytics. FDA recall Z-2221-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2221-2019. Source: US FDA. Licensed CC0.

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