FDA-Device2022-04-06Class II

MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484

Baxter Healthcare Corporation
Hazard

Devices distributed lacked regulatory clearance.

Sold states
US Nationwide distribution in the states of California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, and Texas.
Affected count
498 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0831-2022

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