# FDA recall Z-0076-2018

> **Sorin Group USA, Inc.** · Class II · device recall initiated 2017-09-28.

## Product

FlexFlow Venous Cannula Model/Catalog Number 200-200  The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced to allow clamping the proximal end that terminates in a 3/8 inch (9.5 mm) barbed connector for standard cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a malleable wire. Each component is packaged inside a protective sheath in a single sterile, sealed pouch

## Reason for recall

A specific lot of the FlexFlowTM Venous  Cannula, 200-200, is being recalled because it is sharper or pointier than expected.

## Distribution

Worldwide Distribution - US (nationwide) Internationally to  France and Spain

## Key facts

- **Recall number:** Z-0076-2018
- **Recalling firm:** Sorin Group USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-28
- **Report date:** 2017-11-15
- **Termination date:** 2018-10-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Arvada, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0076-2018

## Citation

> AI Analytics. FDA recall Z-0076-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0076-2018. Source: US FDA. Licensed CC0.

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