FDA-Device2021-08-04Class II
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
Merit Medical Systems, Inc.
Hazard
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Sold states
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, ID, IL IN, KS, LA, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, WV, and WY. The countries of Australia, Austria, China, Denmark, Finland, France, Germany, Israel, Japan, Kenya, Kyrgyzstan, Netherlands, New Zealand, Norway, Qatar, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.
Affected count
7,211 devices
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2166-2021Don't want to check this manually?
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