QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
Reported: January 22, 2020 Initiated: November 27, 2019 #Z-0800-2020
Product Description
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.
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 27168
- 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.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705. Recalled by Edwards Lifesciences, LLC. Units affected: 27168.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2020. Severity: Moderate. Recall number: Z-0800-2020.
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