FDA-Device2020-06-10Class II
Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Baxter Healthcare Corporation
Hazard
Potential disconnection of tubing set.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lithuania, Latvia, Montenegro, Morocco, Netherlands, Norway, Poland, Russia, Serbia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, Korea, Singapore, Hong Kong
Affected count
2,361,885 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2193-2020Don't want to check this manually?
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