Recall record at a glance
| Official record | Z-0800-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Edwards Lifesciences, LLC |
| Report date | Jan 22, 2020 |
| Recall initiation date | Nov 27, 2019 |
| Quantity | 27168 |
| Location | Irvine, CA, United States |
Official product description
QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
Why the product was 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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