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Baxter Healthcare Corporation Recall 90032

Description: 15 Liters Drain Bag

Baxter Healthcare Corporation Recall 90032 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1141-2022
Event ID90032
Event Description15 Liters Drain Bag
Product TypeDevices
DistributionUS Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
Quantity510 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: R5C4145P; UDI: 05413760005386; Lot Numbers: H17H14104 (exp. date: 07/31/2022), H20K02117 (exp. date: 11/02/2025), H21H24081 (exp. date: 08/24/2026)
Center Classification Date20220527
Recall Initiation Date20220421
Recalling FirmBaxter Healthcare Corporation
Initial Notification Letter
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