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Terminated

15 Liters Drain Bag

FDA Recall Z-1141-2022 · Posted None

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeKDJ
Date Initiated2022-04-21
Date Terminated2026-05-27
Product Quantity510 units

Reason for Recall

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

Firm Action

An Urgent Medical Device Recall communication was sent to affected peritoneal dialysis centers via U.S.P.S., first class mail on 04/21/2022. Instructions within the communication request customers to locate and return any unused affected product codes and lots from their facility, contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday, and acknowledge the receipt of this notification by completing a reply form on the customer portal or by returning a reply form in the enclosed pre-addressed stamped envelope. The home patient letter was sent on Tuesday, April 26, 2022, via USPS first-class mail.

Root Cause

No Marketing Application

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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