Recall Z-0768-2021
Baxter Healthcare Corporation · initiated November 10, 2020
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
Codes / lots: Product Code: 5C4482, UDI: 00085412007731, Lot#, Expiration Date: H20D13100, 4/13/2025; H20D27084, 4/27/2025; H20D30070, 4/30/2025; H20E13107, 5/13/2025; H20E19054, 5/19/2025; H20E22082, 5/22/2025; H20F09061, 6/9/2025; H20F15050, 6/15/2025; H20F18070, 6/18/2025; H20F24086, 6/24/2025; H20F29051, 6/29/2025; H20G13046, 7/13/2025; H20G27087, 7/27/2025; H20G30065, 7/30/2025; H20H05057, 8/5/2025; H20H14067, 8/14/2025; H20H19066, 8/19/2025
Reason for recall
Potential for no-flow and leaks under the twist clamp.
FDA-determined cause: Process change control
Action taken
Urgent Medical Device Recall FA-2020-055 was sent to Peritoneal Dialysis Centers via U.S.P.S., first class mail on November 10, 2020. Urgent Medical Device Recall FA-2020-055 was sent via U.S.P.S., first class mail on November 13, 2020 to Home Patients who received impacted lots directly from Baxter. Out of an abundance of caution, Baxter will also be mailing the communication to all home patients who receive treatment at Peritoneal Dialysis Centers which received the impacted lots of transfer sets, regardless if the patient received the set or not.
Details
- Recall number
- Z-0768-2021
- Initiated
- November 10, 2020
- Terminated
- March 24, 2023
- Product code
- KDJ – Set, Administration, For Peritoneal Dialysis, Disposable
- Quantity
- 72,771 units
- Distribution
- Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL