Z-0580-2022Class II

Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484

Name: Z-0580-2022 Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484
Creator: Baxter Healthcare Corporation
Published: 2022-01-07
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-01-07 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484 on 2022-01-07. FDA classified it as Class II and gives the reason as "Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0580-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-07
Posted: 2022-02-08
Recalling firm: Baxter Healthcare Corporation
Product: Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484
Product code: KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Reason for recall: Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
FDA root cause: Other
Action: Baxter disseminated a Urgent Medical Device Correction letter on 7 January 2022 to peritoneal dialysis centers and will follow with notice to the patients on 12 January 2022. The notices warned that the use of cleaning products and solvents may cause damage (for example, leaking or cracking), if they come into direct contact with the transfer set. Baxter will be updating the Instructions for Use (IFU) to include a warning against the use of these cleaning products and solvents. For general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176.
Quantity in commerce: 2,240 units
Distribution: Worldwide
Product codes and lots: All lot numbers within expiry

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0580-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0570-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-08
Z-0571-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-08
Z-0572-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-08
Z-0573-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-08
Z-0574-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-08
Z-0575-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-08
Z-0576-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-08
Z-0577-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-08
Z-0578-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-08
Z-0579-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-08
Z-0580-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-08

Product code KDJ

K152675Class IIExtended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and Locking Cap for Titanium Catheter AdapterBaxter Healthcare / cleared 2015-10-29

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)