FDA-Device2022-06-08Class II

5 Prong Manifold Set (with Luer Connectors)

Baxter Healthcare Corporation
Hazard

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Sold states
US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
Affected count
180 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
5 Prong Manifold Set (with Luer Connectors)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1143-2022

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