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U.S. Department of Health and Human Services

Class 2 Device Recall 15 Cycler Drainage Bag

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 Class 2 Device Recall 15 Cycler Drainage Bagsee related information
Date Initiated by FirmOctober 17, 2013
Date PostedOctober 17, 2014
Recall Status1 Terminated 3 on January 04, 2016
Recall NumberZ-0080-2015
Recall Event ID 69253
510(K)NumberK791899 
Product Classification Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
Product15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
Code Information 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
FEI Number 1417572
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer 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 Determined
Cause 2		Component change control
ActionBaxter 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 Commerce3,085,080
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KDJ
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