FDA-Device2022-06-08Class II

3,65 m Extension Set with Luer-lock Connector

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
60 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
3,65 m Extension Set with Luer-lock Connector

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1145-2022

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