Recall Z-0831-2022
Baxter Healthcare Corporation · initiated February 25, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
Codes / lots: 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)
Reason for recall
Devices distributed lacked regulatory clearance.
FDA-determined cause: No Marketing Application
Action taken
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.
Details
- Recall number
- Z-0831-2022
- Initiated
- February 25, 2022
- Terminated
- May 15, 2026
- Product code
- KDJ – Set, Administration, For Peritoneal Dialysis, Disposable
- Quantity
- 498 units
- Distribution
- 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.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL