FDA-Device2023-03-15Class II
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Baxter Healthcare Corporation
Hazard
MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant.
Sold states
US Nationwide distribution and Canada.
Affected count
33,866,400 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1213-2023Don't want to check this manually?
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