Z-2471-2015Class II

MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp

Name: Z-2471-2015 MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp
Creator: Baxter Healthcare Corp.
Published: 2013-02-25
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-02-25 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corp. began a recall of MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adapter for... on 2013-02-25. FDA classified it as Class II and gives the reason as "Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2471-2015
Classification: Class II
Status: Terminated
Initiated: 2013-02-25
Posted: 2015-08-27
Terminated: 2016-03-08
Recalling firm: Baxter Healthcare Corporation
Product: MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.
Product code: KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Reason for recall: Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Baxter sent an IMPORTANT PRODUCT INFORMATION letters dated February 25, 2013 to affected customers via USPS. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached reply form and return it to Baxter by faxing it to 224-270-5457 of scanning the form and e-mailing it to [email protected]. For general questions about this communication can be answered by contacting The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST). Clinical questions can be answered by calling Baxter's Renal Division Clinic Help line at 888-736-2543 x 2 (Monday - Friday, 8:00 AM - 5:00 PM CST).
Quantity in commerce: 260,244 units
Distribution: Worldwide Distribution - US: Nationwide + American Samoa + District of Columbia + Guam + Northern Mariana Islands + Puerto Rico; *** FOREIGN: Antigua, Argentina, Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Chile, Colombia, Cuba, Curacao, Dominican Republic, Ecuador, El Salvador, France (New Caledonia), Guatemala, Guyana, Honduras, Hong Kong, India, Indonesia, Jamaica, Japan, Macau, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Suriname, Taiwan, Thailand, Trinidad and Tobago, United Kingdom (Cayman Islands), Uruguay, Venezuela
Product codes and lots: Product Code: 5C4483; All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2471-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2471-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-27
Z-2472-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-27
Z-2473-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-27
Z-2474-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-27

Product code KDJ

K882498Class IIExtended Life Capd Transfer Set 5C4444Baxter Healthcare Corp / cleared 1988-07-13

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)