Skip to content
Recall Observatory FDA recall evidence

Device product

15 Liters Drain Bag

Z-1141-2022

April 21, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 90032
Status
Terminated
Classification
Class II
Quantity
510 units
Official record key
device-enforcement:Z-1141-2022

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: R5C4145P; UDI: 05413760005386; Lot Numbers: H17H14104 (exp. date: 07/31/2022), H20K02117 (exp. date: 11/02/2025), H21H24081 (exp. date: 08/24/2026)

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.