FDA-Device2023-06-21Class II
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only
Merit Medical Systems, Inc.
Hazard
There is a potential that valve assemblies will not open. preventing fluid from draining.
Sold states
Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.
Affected count
7 units
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1918-2023Don't want to check this manually?
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