# FDA recall Z-0800-2020

> **Edwards Lifesciences, LLC** · Class II · device recall initiated 2019-11-27.

## Product

QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705

## Reason for recall

If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its connector can occur; which can result in significant blood loss.

## Distribution

U.S.: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN,  TX, UT, VA, VT, WA, WI, WV.    O.U.S. (Foreign): Brazil, Colombia, Albania, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Namibia, Poland, Romania, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.

## Key facts

- **Recall number:** Z-0800-2020
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-27
- **Report date:** 2020-01-22
- **Termination date:** 2024-05-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0800-2020

## Citation

> AI Analytics. FDA recall Z-0800-2020. Retrieved 2026-06-22 from https://api.ai-analytics.org/recall/Z-0800-2020. Source: US FDA. Licensed CC0.

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