Recall Z-0768-2021 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Baxter Healthcare Corporation
MiniCap Extended Life PD Transfer Set
| Date | Nov 10, 2020 |
| Status | Terminated |
| Reason | Potential for no-flow and leaks under the twist clamp. |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 72,771 units |
| Distribution | Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192705 | MiniCap Extended Life PD Transfer Sets Baxter Healthcare, Oct 25, 2019 |