FDA-Device2024-10-23Class II
basixSKY Inflation Device, REF: SKY1802
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
70
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
basixSKY Inflation Device, REF: SKY1802
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0071-2025Don't want to check this manually?
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