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Terminated

MiniCap Extended Life PD Transfer Set

FDA Recall Z-0768-2021 · Posted None

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeKDJ
Date Initiated2020-11-10
Date Terminated2023-03-24
Product Quantity72,771 units

Reason for Recall

Potential for no-flow and leaks under the twist clamp.

Firm 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.

Root Cause

Process change control

Distribution Pattern

Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192705MiniCap Extended Life PD Transfer SetsBaxter Healthcare · 2019-10-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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