Z-0800-2020 Class II Terminated
FDA device recall Z-0800-2020 was initiated by Edwards Lifesciences, LLC on November 27, 2019 and is designated Class II. 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 conn… The recall status is terminated (terminated May 28, 2024). Affected quantity: 27168.
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2020
- Initiation Date
- November 27, 2019
- Termination Date
- May 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27168
Product Description
Reason for Recall
Distribution Pattern
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.