FDA recall Z-1146-2022

Baxter Healthcare Corporation · Class II · device

Product

APD Drain Manifold

Reason for recall

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

Distribution

US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.

Key facts

Status
Ongoing
Initiation date
2022-04-21
Report date
2022-06-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1146-2022