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Recall Observatory FDA recall evidence

Device product

APD Drain Manifold

Z-1146-2022

April 21, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 90032
Status
Terminated
Classification
Class II
Quantity
180 units
Official record key
device-enforcement:Z-1146-2022

Official wording

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

Code information: Product code: R5C4512; UDI: 00085412008790; Lot Number: H18D03030 (exp. date: 04/03/2023), Lot Number: H18E31046 (exp. date: 05/31/2023), Lot Number: H18L04065 (exp. date:12/04/2023), Lot Number: H20H10073 (exp. date: 08/10/2022)

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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