Z-0080-2015Class II

15 L Cycler Drainage Bag

Name: Z-0080-2015 15 L Cycler Drainage Bag
Creator: Baxter Healthcare Corp
Published: 2013-10-17
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-10-17 / Terminated

FDA source

Baxter Healthcare Corp began a recall of 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory on 2013-10-17. FDA classified it as Class II and gives the reason as "The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0080-2015
Classification: Class II
Status: Terminated
Initiated: 2013-10-17
Posted: 2014-10-17
Terminated: 2016-01-04
Recalling firm: Baxter Healthcare Corporation
Product: 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
Product code: KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Reason for recall: The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.
FDA root cause: Component change control
Action: Baxter sent an Urgent Product Recall letter dated May 30, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. The recalling firm is instructing their customers to remove all affected products from their facility and quarantine the product subject to the recall. Customers are instructed to return the affected product to Baxter and receive a credit or replacement. For questions contact the Center for One Baxter at 1-800-422-9837.
Quantity in commerce: 3,085,080
Distribution: Worldwide Distribution - US Nationwide (including Puerto Rico) and countries of, Canada, Australia, New Zealand, Thailand, Malaysia, Singapore, Korea, Japan, Philippines, Columbia, Ecuador, Austria, Bahran, Belgium, Bosnia & Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Ireland, Isreal, Italy, Jordan, Kazakhstan, Latvia, Luxembourg, Malta, Norway, Oman, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovakia, South Africa, Spain (including Canary Islands), Sweden, Switzerland, The Netherlands, Turkey and United Arad Emirates.
Product codes and lots: Lot numbers: H12K20044, H12K20085, H12K21026, H13B04052, H13B04086, H13B05042, H13B05067, H13B06073, H13B07063, H13B13087, H13B14069, H13B14085, H13B15066, H13B18029, H13B18084, H13B20108, H13B22013, H13B22062, H13B23060, H13B24043, H13B25032, H13B25107, H13C06030, H13C06055, H13C07053, H13C07087, H13C08051, H13C09026, H13C09034, H13C09075, H13C11089, H13C12046, H13C12061, H13C13069, H13C19124, H13C20031, H13C20106, H13C21054, H13C22029, H13C25048, H13C25071, H13C26038, H13C26137, H13D02086, H13D03068, H13D04033, H13D04108, H13D10089, H13D10097, H13D11087, H13D12051, H13D12101, H13D13034, H13D13067, H13D15070, H13D15112, H13D16078, H13D16110, H13D19056, H13D19098, H13D20013, H13D20062, H13D21029, H13D22043, H13D22084, H13D23025, H13D23041, H13D24064, H13D25020, H13D25095, H13E01036, H13E01077, H13E02026, H13E02091, H13E03016, H13E07116, H13E08023, H13E08049, H13E09070, H13E10011, H13E10029, H13E13015, H13E13031, H13E14088, H13E14104, H13E15036, H13E21083, H13E22073, H13E23022, H13E23055, H13E24012, H13E24061, H13E28047, H13E28088, H13E29029, H13E30035, H13E30092, H13F04095, H13F04129, H13F05084, H13F06025, H13F06060, H13F07056, H13F11033, H13F12049, H13F12072, H13F12122, H13F13039, H13F13070, H13F14094, H13F18087, H13F19036, H13F20018, H13F20091, H13F21016, H13F21073, H13F22014, H13F22063, H13F25041, H13F25090, H13F26031, H13F26072, H13F27013, H13F27054, H13F28029, H13G09084, H13G10025, H13G10124, H13G11064, H13G12039, H13G12088, H13G16105, H13G17046, H13G18010, H13G18101, H13G19067, H13G19109, H13G23069, H13G24018, H13G24075, H13G25015, H13G25023, H13G26013, H13G26070, H13G31054, H13G31104, H13H01055, H13H02012, H13H02095, H13H05049, H13H06054, H13H06120, H13H07045, H13H13019, H13H13035, H13H13092, H13H14025, H13H14090, H13H15048, H13H15105, H13H20030, H13H20063, H13H21046, H13H21079, H13H22028, H13H22077, H13H23042

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0080-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0080-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16

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)