FDA-Device2020-03-11Class II

Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L

Baxter Healthcare Corporation
Hazard

There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.

Sold states
Nationwide
Affected count
101976 devices
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1409-2020

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