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Merit Medical Systems, Inc. recalls basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or othe
Recalled August 4, 2021 · FDA recall Z-2166-2021 · Merit Medical Systems
Hazard
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn. · FDA Class II
Units
7,211 devices
Sold at
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.
Description
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Product
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.
Manufacturer(s)
Merit Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →