MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- February 25, 2022
- Recall Number
- Z-0831-2022
- Quantity
- 498 units
- Firm Location
- Deerfield, IL
Reason for Recall
Devices distributed lacked regulatory clearance.
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.
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)
Root 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.