Baxter Healthcare Corp: 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.

Recall number

Z-0080-2015

Recalling firm

Baxter Healthcare Corp

Product

15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.

Status

Terminated

Initiated

2013-10-17

Posted

2014-10-17

Terminated

2016-01-04

Reason

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.

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

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.

Lot, serial or model codes

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

510(k) numbers

["K791899"]

PMA numbers

not on file

Product code

KDJ

Firm FEI

1417572

Firm city

Deerfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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