Z-2246-2017Class II

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter...

Name: Z-2246-2017 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter...
Creator: Baxter Healthcare Corporation
Published: 2014-04-28
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2014-04-28 / Terminated

FDA source

Baxter Healthcare Corporation began a recall of Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA on 2014-04-28. FDA classified it as Class II and gives the reason as "Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2246-2017
Classification: Class II
Status: Terminated
Initiated: 2014-04-28
Posted: 2017-06-02
Terminated: 2017-07-21
Recalling firm: Baxter Healthcare Corporation
Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Product code: KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Reason for recall: Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis.
FDA root cause: Unknown/Undetermined by firm
Action: On April 28, 2014, firm sent an Urgent Product Recall to US customers via USPS 1st class mail. Baxter requested customers to locate and remove all affected product from their facility, and contact Baxter Healthcare Center for Service to arrange for return and credit. 100%, all non-respondents would be contacted by phone. All affected product would be destroyed. For general questions regarding this communication , contact The Center for One Baxter at 1-800-422-9837 , Monday through Friday, between the hours of 8:00AM and 5:00 PM Central Time.
Quantity in commerce: 6,048
Distribution: Nationwide Distribution and Internationally to Canada and Malaysia
Product codes and lots: Product Code 5C4483; Lot# H12030047

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2246-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2246-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)