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Baxter Healthcare Corporation Recall 90032

Description: APD Drain Manifold

Baxter Healthcare Corporation Recall 90032 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1146-2022
Event ID90032
Event DescriptionAPD Drain Manifold
Product TypeDevices
DistributionUS Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
Quantity180 units
Recall ReasonCertain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Device Classification20220608
Device Code InfoProduct 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)
Center Classification Date20220527
Recall Initiation Date20220421
Recalling FirmBaxter Healthcare Corporation
Initial Notification Letter
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