15 L Cycler Drainage Bag Product Usage: For use with recall
15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
Why was 15 L Cycler Drainage Bag Product Usage: For use with recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
- Recalling firm
- Baxter Healthcare Corp
- 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.
- Recall date
- October 22, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)