FDA-Device2024-10-23Class II
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Merit Medical Systems, Inc.
Hazard
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Sold states
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.
Affected count
12,910
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0069-2025Don't want to check this manually?
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