# FDA recall Z-0102-2019

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

## Product

Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO

## Reason for recall

The catheter failed the endotoxin testing.

## Distribution

US Nationwide in the states of NY, AR, MO, NC, GA, LA, CO, AL, MA, CA, MI, TX, OH, MD, FL, TN, SC, OR, AZ, UT, RI, SD, PA, NM, CT.    Foreign (OUS): United Arab Emirates, Kingdom of Saudi Arabia, New Zealand, Thailand

## Key facts

- **Recall number:** Z-0102-2019
- **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:** 2021-10-05

- **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-0102-2019

## Citation

> AI Analytics. FDA recall Z-0102-2019. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0102-2019. Source: US FDA. Licensed CC0.

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