Z-0768-2021Class II

MiniCap Extended Life PD Transfer Set

Name: Z-0768-2021 MiniCap Extended Life PD Transfer Set
Creator: Baxter Healthcare Corporation
Published: 2020-11-10
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2020-11-10 / Terminated

FDA source

Baxter Healthcare Corporation began a recall of MiniCap Extended Life PD Transfer Set on 2020-11-10. FDA classified it as Class II and gives the reason as "Potential for no-flow and leaks under the twist clamp". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0768-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-10
Posted: 2021-01-04
Terminated: 2023-03-24
Recalling firm: Baxter Healthcare Corporation
Product: MiniCap Extended Life PD Transfer Set
Product code: KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Reason for recall: Potential for no-flow and leaks under the twist clamp.
FDA 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 in commerce: 72,771 units
Distribution: Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0768-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0768-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-04

Product code KDJ

K192705Class IIMiniCap Extended Life PD Transfer SetsBaxter Healthcare / cleared 2019-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)