Recalls / —

—#191841

Product

MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484

FDA product code

KDJ — Set, Administration, For Peritoneal Dialysis, Disposable

Device class

Class 2

Medical specialty

Gastroenterology, Urology

Affected lot / code info

Product Code 5C4482S, UDI: 0085412476261; Lot Number (Expiration Date): H20F02074 (06/02/2025) and H21C31053 (03/31/2026) Product Code R5C4482, UDI: 0085412008776; Lot Number (Expiration Date): H18E18050 (05/18/2023), H20K06084 (11/06/2025), H20L08070 (12/08/2025), H21E07058 (05/07/2026), H21F07049 (06/07/2026), H21F08070 (06/08/2026), H21F28060 (06/28/2026), H21K16066 (11/16/2026) Product Code R5C4483, UDI: 0085412008783; Lot Number (Expiration Date): H18A12037 (01/12/2023) and H20K06035 (11/06/2025) Product Code R5C4484, UDI: 0085412050768; Lot Number (Expiration Date): H17H03057 (08/03/2022), H18G16076 (07/16/2023), H19E31052 (05/31/2024), H21B16056 (02/16/2026)

Why it was recalled

Devices distributed lacked regulatory clearance.

Root cause (FDA determination)

No Marketing Application

Action the firm took

An Urgent Medical Device Recall communication was sent to affected customers via U.S.P.S., first class mail on 02/25/2022. 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.

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

US Nationwide distribution in the states of California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, and Texas.

Timeline

Recall initiated

2022-02-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #191841. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.