# FDA recall Z-1230-2019

> **OriGen Biomedical, Inc.** · Class I · device recall initiated 2017-01-17.

## Product

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F

## Reason for recall

Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.

## Distribution

US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM.    Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile

## Key facts

- **Recall number:** Z-1230-2019
- **Recalling firm:** OriGen Biomedical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-01-17
- **Report date:** 2019-06-12
- **Termination date:** 2021-07-27

- **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-1230-2019

## Citation

> AI Analytics. FDA recall Z-1230-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1230-2019. Source: US FDA. Licensed CC0.

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