FDA-Device2014-01-08Class II
IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.
Baxter Healthcare Corp.
Hazard
Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill i.v. Pharmacy Compounding Device (PCD) (product code: IFIV) has the potential to continue to run and fill syringes with the HEPA filtration disabled.
Sold states
Nationwide Distribution including the states of CA, CO, CT, FL, IL, LA, MA, MD, MI, NC, NE, NY, OH, OR, PA, TN, TX, and WV.
Affected count
28 devices
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0607-2014Don't want to check this manually?
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