FDA-Device2014-07-23Class II

Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.

Baxter Healthcare Corp.
Hazard

Inadequate iodine and packaging related defects.

Sold states
Distributed USA (nationwide) and Canada.
Affected count
585,360 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2074-2014

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