Recall Z-0567-2025 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
| Date | Nov 27, 2024 (initiated Oct 23, 2024) |
| Status | Open, Classified |
| Reason | There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| Root cause | Under Investigation by firm |
| Action | Baxter issued a SAFETY ALERT notice to its consignees on 10/23/2024 via USPS first class mail. The notice explains the issue and potential hazard involved. The notice addressed to dialysis providers indicated that if a patient contacts your clinic experiencing separation of the transfer set, to replace their transfer set and contact Baxter. Notices addressed to peritoneal patients provided the following instructions: "If you experience a separation of the transfer set, please close the transfer set twist clamp and do not cut the patient line. Contact your doctor and/or nurse immediately to |
| Quantity | 1496 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.