—#193248

Product

Locking Cap for PD Catheter Adapter

FDA product code: KDJ — Set, Administration, For Peritoneal Dialysis, Disposable
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Product code: R5C4169; UDI: 00085412008639; Lot Number: H20K02067 (exp. date: 10/31/2025)

Why it was recalled

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

Root cause (FDA determination)

No Marketing Application

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

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

Timeline

Recall initiated: 2022-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193248. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.