Z-0194-2016Class II

Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

Name: Z-0194-2016 Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Creator: Baxter Healthcare Corp.
Published: 2015-10-06
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2015-10-06 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path on 2015-10-06. FDA classified it as Class II and gives the reason as "Leakage from the inlet port of the 15L Cycler Drainage Bags". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0194-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-06
Posted: 2015-10-30
Terminated: 2016-06-27
Recalling firm: Baxter Healthcare Corporation
Product: Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Product code: KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Reason for recall: Leakage from the inlet port of the 15L Cycler Drainage Bags.
FDA root cause: Under Investigation by firm
Action: Baxter sent an Urgent Product Recall letter dated October 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalling firm will ask customers to locate and separate all affected products, contact the recalling firm to arrange for a return, and complete the customer reply form. Further questions, please call (800) 422-9837.
Quantity in commerce: 19,440 units
Distribution: US Distribution and Internationally to Canada.
Product codes and lots: H15C11095

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0194-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0194-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-10-30

Product code KDJ

K791899Class IICycler Sets Mod. #5C4143, 5C4144, 5C4145Travenol Laboratories, S.A. / cleared 1979-11-13

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)