# FDA recall Z-0181-2019

> **OriGen Biomedical, Inc.** · Class II · device recall initiated 2018-08-21.

## Product

Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO     Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

## Reason for recall

These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip

## Distribution

Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of:  Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN, Thailand, UK, United Arab Emirates, and VIETNAM.

## Key facts

- **Recall number:** Z-0181-2019
- **Recalling firm:** OriGen Biomedical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-21
- **Report date:** 2018-10-24
- **Termination date:** 2021-07-15

- **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-0181-2019

## Citation

> AI Analytics. FDA recall Z-0181-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0181-2019. Source: US FDA. Licensed CC0.

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