# FDA recall Z-0269-2019

> **OriGen Biomedical, Inc.** · Class I · device recall initiated 2015-03-30.

## Product

REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473     Product Usage:  The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

## Reason for recall

Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage

## Distribution

Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI    OUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia, Poland, Spain Sweden, Thailand and United Kingdom

## Key facts

- **Recall number:** Z-0269-2019
- **Recalling firm:** OriGen Biomedical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2015-03-30
- **Report date:** 2018-11-14
- **Termination date:** 2024-03-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0269-2019

## Citation

> AI Analytics. FDA recall Z-0269-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0269-2019. Source: US FDA. Licensed CC0.

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