Set, Administration, For Peritoneal Dialysis, Disposable
FDA product code KDJ · Class II (moderate risk) · 21 CFR 876.5630 · Gastroenterology, Urology
113510(k) clearances
0PMA approvals
59recalls
Manufacturers
- National Medical Care, Medical Products Div., Inc. 30
- Baxter Healthcare Corp 16
- Travenol Laboratories, S.A. 12
- American Medical Products, Inc. 7
- Abbott Laboratories 7
- Delmed, Inc. 6
- Fresenius Medical Care Renal Therapies Group, LLC 4
- Fresenius USA, Inc. 3
- Dravon Medical, Inc. 3
- Fresenius Medical Care North America 3
- Microwave Medical Systems, Inc. 2
- Medionics International , Ltd. 2
- Physio-Control Corp. 2
- American Mcgaw 1
- Rogo Ent. 1
- Clinipad Corp. 1
- Gambro, Inc. 1
- Norton Performance Plastics Corp. 1
- Intermed, Inc. 1
- Millipore Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250404 | staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter…KDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 04/03/2025SE |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional | Baxter Healthcare | 03/12/2024SE |
| K214016 | 15L Cycler Drainage BagKDJ · Traditional | Baxter Healthcare Corporation | 03/18/2022SE |
| K192705 | MiniCap Extended Life PD Transfer SetsKDJ · Special | Baxter Healthcare | 10/25/2019SE |
| K173593 | staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension…KDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/21/2018SE |
| K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetKDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/14/2018SE |
| K173363 | Cycler Drain Bag SetKDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 01/24/2018SE |
| K151620 | Firefly Peritoneal Dialysis Connector Disinfection SystemKDJ · Traditional | Puracath Medical, Inc. | 01/20/2016SE |
| K152675 | Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and…KDJ · Traditional | Baxter Healthcare | 10/29/2015SE |
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine…KDJ · Traditional | Baxter Healthcare Corporation | 10/29/2015SE |
| K124024 | Apd Luer-Lock AdapterKDJ · Traditional | Fresensius Medical Care North America | 09/19/2013SE |
| K083542 | Fresenius Sterile Stay Safe CapKDJ · Traditional | Fresenius Medical Care North America | 12/29/2008SE |
| K042900 | K.E.P. Connector and ClipKDJ · Traditional | K.E.P., LLC | 11/05/2004SE |
| K041792 | Fresenius Staysafe Patient Connectors, Model 050-87211KDJ · Traditional | Fresenius Medical Care North America | 09/24/2004SE |
| K031676 | Homechoice Apd Set with Lineo Connector, Models 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q…KDJ · Traditional | Baxter Healthcare Corp | 11/20/2003SE |
| K022412 | Fresenius Capd Stay.Safe Disposable Administration Sets with Stay.Safe ConnectorKDJ · Traditional | Fresenius Medical Care North America | 03/05/2003SE |
| K974387 | PDM3 Disinfection System for Peritoneal Dialysis Exchanges, Patient Transfer Set PTS102…KDJ · Traditional | Microwave Medical Systems, Inc. | 09/01/1999SE |
| K972579 | High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose Disconnect Cap with…KDJ · Traditional | Baxter Healthcare Corp | 10/01/1997SE |
| K972731 | Neo-Care Peritoneal Dialysis Administration SetKDJ · Traditional | Klein-Baker Medical, Inc. | 09/29/1997SE |
| K963668 | Medisystems Peritoneal Dialysis SetsKDJ · Traditional | Medisystems Corp. | 08/15/1997SE |
| K961825 | ULTRASET/3L Capd Disposable Disconnect Y-Set Models 5C4366 & 5C4493KDJ · Traditional | Baxter Healthcare Corp | 08/06/1996SE |
| K945567 | QC CapKDJ · Traditional | Medionics International, Inc. | 02/07/1995SE |
| K930843 | Rapid Disconnect Y-Set, Cat. No. 48-7000KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 08/31/1994SE |
| K921818 | Abbott Smart CapKDJ · Traditional | Abbott Laboratories | 03/28/1994SE |
| K925403 | Baxter Apd 12' Extension LineKDJ · Traditional | Baxter Healthcare Corp | 02/22/1994SE |
| K921052 | Fresenius Variable Fill MonitorKDJ · Traditional | Fresenius USA, Inc. | 02/25/1993SE |
| K920586 | Dextrolyte II Peritoneal Dialysis Admin. SetKDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 09/21/1992SE |
| K920029 | Dextrolyte II Capd Trnsfer SetKDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 09/21/1992SE |
| K915628 | Dextrolyte II Peritoneal Dialysis PumpKDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/16/1992SE |
| K915304 | Abbott Smart CapKDJ · Traditional | Abbott Laboratories | 02/19/1992SE |
| K912208 | Fresenius Safe-Connect Capd Manual Assist DeviceKDJ · Traditional | Fresenius USA, Inc. | 07/24/1991SE |
| K904806 | Capd Safelock Transfer Set W/Pre-Filled ConnectorKDJ · Traditional | Fresenius USA, Inc. | 01/11/1991SE |
| K900295 | Peritoneal Dialysis Stystem and AccessoriesKDJ · Traditional | Microwave Medical Systems, Inc. | 11/21/1990SE |
| K903869 | 90/2 Peritoneal Dialysis System Dispos Cycler SetKDJ · Traditional | Fresenius/Delmed, Inc. | 11/20/1990SE |
| K902526 | Capd Disposable Disconnect Y-Set Code: 5C4481KDJ · Traditional | Baxter Healthcare Corp | 11/20/1990SE |
| K902451 | Long-Life Y-Set Cat. No. 48-6366-8KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 08/14/1990SE |
| K900106 | Closed Disconnect SystemKDJ · Traditional | Delmed, Inc. | 07/16/1990SE |
| K895992 | Catheter Extension Set Cat. No. 48-3027-9KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/23/1990SE |
| K895792 | Dextrolyte II Capd Transfer Set - No. 48-4009-6KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/23/1990SE |
| K900323 | Peritoneal Dialysis Cycler SetKDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/22/1990SE |
| K900243 | Dextrolyte II, Peritoneal Dialysis No. 48-1015-6KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/22/1990SE |
| K900242 | Dextrolyte II, Peritoneal Dialysis No. 48-1031-3KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/22/1990SE |
| K900226 | Dextrolyte II, Peritoneal Dialysis No. 48-1001-6KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/22/1990SE |
| K900142 | Dextrolyte II, W/5 Prong Manifold No. 48-1003-2KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/22/1990SE |
| K900141 | Dextrolyte II, W/5 Prong Manifold No. 48-1100-6KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/22/1990SE |
| K900140 | Dextrolyte II, Peritoneal Dialysis Cycler Set W/3KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/22/1990SE |
| K900012 | Dextrolyte II, Peritoneal Dialysis Cycler SetKDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/22/1990SE |
| K900008 | Dextrolyte II, Peritoneal Dialysis Cycler SetKDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/22/1990SE |
| K896600 | Dextrolyte II, Single Use Y Set No. 48-6360-1KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/22/1990SE |
| K896599 | Dextrolyte II, Peritoneal Dialysis Cycler Set -(8)KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/22/1990SE |
| K895991 | Peritoneal Dialysis Drainage Set No. 48-0025-6KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/22/1990SE |
| K895990 | Dextrolyte II Peritoneal Dialysis Cycler SetKDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/22/1990SE |
| K900005 | Dextrolyte II, Manual Administration Set 48-1032-1KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 03/02/1990SE |
| K900006 | Catheter Adapter Sealing Cap No. 48-1028-9KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 02/27/1990SE |
| K900004 | Convertible Adapter Catalog No. 48-4039-3KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 02/27/1990SE |
| K896956 | Quick Disconnect Clamp Catalog No. 48-0300-3KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 02/27/1990SE |
| K896764 | Universal Connector Catalog No. 48-1025-5KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 02/26/1990SE |
| K896763 | Catheter Adapter Co-Pak Catalog No. 48-0122-1KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 02/26/1990SE |
| K896761 | Transfer Set Sealing Cap, Cat. No. 48-1027-1KDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 02/26/1990SE |
| K895673 | Connection Shields Codes 5C4213 and 5C4215KDJ · Traditional | Baxter Healthcare Corp | 01/29/1990SE |
| K895631 | Disconnect Caps Product Codes 5C4212 and 5C4466KDJ · Traditional | Baxter Healthcare Corp | 01/29/1990SE |
| K894783 | Peritoneal Dial. Tita. Cath Adapter & Locking CapKDJ · Traditional | Baxter Healthcare Corp | 09/07/1989SE |
| K893712 | Peritoneal Dialysis System and Access.KDJ · Traditional | Delmed, Inc. | 07/24/1989SE |
| K893231 | DelclampKDJ · Traditional | Delmed, Inc. | 06/08/1989SE |
| K892872 | Peritoneal Dialysis Cycler Set W/12 Prong ManifoldKDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 05/18/1989SE |
| K892871 | Peritoneal Dialysis Cycler Set, W/8 Prong ManifoldKDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 05/18/1989SE |
| K892870 | Peritoneal Dialysis Cycler Set, W/5 Prong ManifoldKDJ · Traditional | National Medical Care, Medical Products Div., Inc. | 05/18/1989SE |
| K883393 | Capd Disposable Y System - Dy SetKDJ · Traditional | Medionics International , Ltd. | 11/03/1988SE |
| K883239 | Capd Ultraviolet(U.V.) Germicidal Exchange Dev SysKDJ · Traditional | Baxter Healthcare Corp | 10/21/1988SE |
| K882498 | Extended Life Capd Transfer Set 5C4444KDJ · Traditional | Baxter Healthcare Corp | 07/13/1988SE |
| K882455 | Extended Life Capd Solution Transfer Set IC4373KDJ · Traditional | Baxter Healthcare Corp | 07/13/1988SE |
| K873984 | Automatic Peritoneal Dialysis Cycler Set (5C4437)KDJ · Traditional | Travenol Laboratories, S.A. | 10/20/1987SE |
| K871155 | Delflex Rigid Drain ContainerKDJ · Traditional | Delmed, Inc. | 07/16/1987SE |
| K871583 | Modified Labeling for AMUKIN-50%KDJ · Traditional | Amuchina Intl., Inc. | 07/09/1987SE |
| K870626 | Freedom Set II with Triflex ValveKDJ · Traditional | Delmed, Inc. | 06/03/1987SE |
| K871154 | Delflex Safe Lock Capd Patient Assist DeviceKDJ · Traditional | Delmed, Inc. | 04/30/1987SE |
| K871050 | Capd Admin. Set Used W/Inpersol Capd Biocap Y-Adm.KDJ · Traditional | Abbott Laboratories | 04/10/1987SE |
| K871049 | Capd Y-Admin. Set Used W/Inpersol Biocap Admin.KDJ · Traditional | Abbott Laboratories | 04/10/1987SE |
| K870145 | External Y Valve 5C4198KDJ · Traditional | Travenol Laboratories, S.A. | 03/10/1987SE |
| K860700 | Capd Disconnect System 5C4182, 5C4183, 5C4186KDJ · Traditional | Travenol Laboratories, S.A. | 04/07/1986SE |
| K860230 | Capd Transfer Set Spike 5C4363KDJ · Traditional | Travenol Laboratories, S.A. | 02/05/1986SE |
| K853550 | Travenol Capd Y Set 5C4354KDJ · Traditional | Travenol Laboratories, S.A. | 10/04/1985SE |
| K852678 | Capd Transfer Set for Reduced Fill Volumes 5C4353KDJ · Traditional | Travenol Laboratories, S.A. | 07/29/1985SE |
| K851208 | Compact Exchange Device 5C4197KDJ · Traditional | Travenol Laboratories, S.A. | 04/08/1985SE |
| K851207 | Extended Life Capd Solution Transfer Set 5C4153KDJ · Traditional | Travenol Laboratories, S.A. | 04/08/1985SE |
| K820546 | Card U.V. Germicidal Chamber IIKDJ · Traditional | Travenol Laboratories, S.A. | 06/30/1982SE |
| K812802 | Capd U.V. Germicidal Connection SystemKDJ · Traditional | Travenol Laboratories, S.A. | 03/02/1982SE |
| K813069 | Peritoneal Dialysis Cycler SetKDJ · Traditional | American Medical Products, Inc. | 11/16/1981SE |
| K812772 | Peritoneal Dialysis Cycler Set (8UNIT)KDJ · Traditional | Dravon Medical, Inc. | 10/19/1981SE |
| K812771 | Peritoneal Dialysis DrainageKDJ · Traditional | Dravon Medical, Inc. | 10/19/1981SE |
| K811863 | Steri-TractKDJ · Traditional | Rogo Ent. | 09/21/1981SE |
| K812130 | Spike GuardKDJ · Traditional | Clinipad Corp. | 09/09/1981SE |
| K811294 | Gambro Peritoneal Dialysis Fluid LinesKDJ · Traditional | Gambro, Inc. | 06/12/1981SE |
| K810840 | Amp Peritoneal Dialysis Prep KitKDJ · Traditional | American Medical Products, Inc. | 04/29/1981SE |
| K810671 | CCPD 3 Liter Drainage SetKDJ · Traditional | American Medical Products, Inc. | 03/24/1981SE |
| K810670 | CCPD Cycler SetKDJ · Traditional | American Medical Products, Inc. | 03/24/1981SE |
| K810600 | Capd Exchange SetKDJ · Traditional | American Mcgaw | 03/24/1981SE |
| K803300 | Inpersol Capd Bag Port ClampKDJ · Traditional | Abbott Laboratories | 01/29/1981SE |
| K801881 | Inpersol-Capd Administration SetKDJ · Traditional | Abbott Laboratories | 10/10/1980SE |
| K801220 | Peritoneal Dialysis Cycler Set W/PumpKDJ · Traditional | American Medical Products, Inc. | 08/12/1980SE |
| K801193 | Clirans TE15 Hollow Fiber DialyzerKDJ · Traditional | Terumo America, Inc. | 08/12/1980SE |
| K800993 | Inpersol Capd Admin. Set & Catheter AdapKDJ · Traditional | Abbott Laboratories | 08/12/1980SE |
| K792651 | Capd Transfer Set JC9044KDJ · Traditional | Travenol Laboratories, S.A. | 02/06/1980SE |
| K791512 | Continuous Ambulatory Dialysis (Capd)KDJ · Traditional | Norton Performance Plastics Corp. | 02/06/1980SE |
| K791722 | Disposable Peritoneal Dialysis ExtensionKDJ · Traditional | American Medical Products, Inc. | 11/16/1979SE |
| K791899 | Cycler Sets Mod. #5C4143, 5C4144, 5C4145KDJ · Traditional | Travenol Laboratories, S.A. | 11/13/1979SE |
| K791426 | Peritoneal PacKDJ · Traditional | Intermed, Inc. | 08/28/1979SE |
| K781755 | Dap-PakKDJ · Traditional | Dravon Medical, Inc. | 02/15/1979SE |
| K780957 | Set, Administration, Manual, DialysisKDJ · Traditional | American Medical Products, Inc. | 07/06/1978SE |
| K780082 | Peritoneal Dialysis Admin. SetKDJ · Traditional | Physio-Control Corp. | 01/24/1978SE |
| K772236 | Filter, Peritoneal Dialy. Admin. SetKDJ · Traditional | Millipore Corp. | 01/24/1978SE |
| K771482 | Rinse Block ConnectorKDJ · Traditional | Quinton, Inc. | 01/03/1978SE |
| K772136 | Peritoneal Cycler & Manifold SetKDJ · Traditional | Physio-Control Corp. | 12/20/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0569-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number…There has been an increase in the number of complaints related to the separation of the female connector… | Baxter Healthcare Corporation | 10/23/2024Open, Classified |
| Z-0568-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number…There has been an increase in the number of complaints related to the separation of the female connector… | Baxter Healthcare Corporation | 10/23/2024Open, Classified |
| Z-0567-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use…There has been an increase in the number of complaints related to the separation of the female connector… | Baxter Healthcare Corporation | 10/23/2024Open, Classified |
| Z-0566-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use…There has been an increase in the number of complaints related to the separation of the female connector… | Baxter Healthcare Corporation | 10/23/2024Open, Classified |
| Z-0565-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use…There has been an increase in the number of complaints related to the separation of the female connector… | Baxter Healthcare Corporation | 10/23/2024Open, Classified |
| Z-0564-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use…There has been an increase in the number of complaints related to the separation of the female connector… | Baxter Healthcare Corporation | 10/23/2024Open, Classified |
| Z-0563-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use…There has been an increase in the number of complaints related to the separation of the female connector… | Baxter Healthcare Corporation | 10/23/2024Open, Classified |
| Z-0562-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use…There has been an increase in the number of complaints related to the separation of the female connector… | Baxter Healthcare Corporation | 10/23/2024Open, Classified |
| Z-0561-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use…There has been an increase in the number of complaints related to the separation of the female connector… | Baxter Healthcare Corporation | 10/23/2024Open, Classified |
| Z-0560-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use…There has been an increase in the number of complaints related to the separation of the female connector… | Baxter Healthcare Corporation | 10/23/2024Open, Classified |
| Z-0559-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use…There has been an increase in the number of complaints related to the separation of the female connector… | Baxter Healthcare Corporation | 10/23/2024Open, Classified |
| Z-0382-2025 Class I | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number…Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to… | Baxter Healthcare Corporation | 10/21/2024Open, Classified |
| Z-0381-2025 Class I | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use…Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to… | Baxter Healthcare Corporation | 10/21/2024Open, Classified |
| Z-0380-2025 Class I | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use…Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to… | Baxter Healthcare Corporation | 10/21/2024Open, Classified |
| Z-0379-2025 Class I | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use…Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to… | Baxter Healthcare Corporation | 10/21/2024Open, Classified |
| Z-0378-2025 Class I | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use…Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to… | Baxter Healthcare Corporation | 10/21/2024Open, Classified |
| Z-0377-2025 Class I | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use…Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to… | Baxter Healthcare Corporation | 10/21/2024Open, Classified |
| Z-0376-2025 Class I | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use…Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to… | Baxter Healthcare Corporation | 10/21/2024Open, Classified |
| Z-0375-2025 Class I | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use…Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to… | Baxter Healthcare Corporation | 10/21/2024Open, Classified |
| Z-0374-2025 Class I | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use…Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to… | Baxter Healthcare Corporation | 10/21/2024Open, Classified |
| Z-0373-2025 Class I | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use…Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to… | Baxter Healthcare Corporation | 10/21/2024Open, Classified |
| Z-1327-2024 Class I | stay-safe /Luer Catheter Ext. 6 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Fresenius Medical Care Holdings, Inc. | 01/23/2024Open, Classified |
| Z-1326-2024 Class I | stay-safe /Luer Lock Catheter Ext. 18 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Fresenius Medical Care Holdings, Inc. | 01/23/2024Open, Classified |
| Z-1325-2024 Class I | stay-safe /Luer Lock Catheter Ext. 12 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Fresenius Medical Care Holdings, Inc. | 01/23/2024Open, Classified |
| Z-1324-2024 Class I | stay-safe /Luer Lock Adapter 4 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Fresenius Medical Care Holdings, Inc. | 01/23/2024Open, Classified |
| Z-1323-2024 Class I | stay-safe /Safe Lock Catheter Ext. 12 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Fresenius Medical Care Holdings, Inc. | 01/23/2024Open, Classified |
| Z-0507-2024 Class II | Stay Safe CapUpdating the labeling to include additional warnings and contraindications for potential side effects. | Fresenius Medical Care Holdings, Inc. | 10/10/2023Open, Classified |
| Z-1213-2023 Class II | Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to…MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly… | Baxter Healthcare Corporation | 02/01/2023Open, Classified |
| Z-1146-2022 Class II | APD Drain ManifoldCertain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within… | Baxter Healthcare Corporation | 04/21/2022Terminated |
| Z-1145-2022 Class II | 3,65 m Extension Set with Luer-lock ConnectorCertain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within… | Baxter Healthcare Corporation | 04/21/2022Terminated |
| Z-1143-2022 Class II | 5 Prong Manifold Set (with Luer Connectors)Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within… | Baxter Healthcare Corporation | 04/21/2022Terminated |
| Z-1142-2022 Class II | Locking Cap for PD Catheter AdapterCertain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within… | Baxter Healthcare Corporation | 04/21/2022Terminated |
| Z-1141-2022 Class II | 15 Liters Drain BagCertain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within… | Baxter Healthcare Corporation | 04/21/2022Terminated |
| Z-0831-2022 Class II | MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484Devices distributed lacked regulatory clearance. | Baxter Healthcare Corporation | 02/25/2022Terminated |
| Z-0580-2022 Class II | Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | Baxter Healthcare Corporation | 01/07/2022Open, Classified |
| Z-0579-2022 Class II | Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | Baxter Healthcare Corporation | 01/07/2022Open, Classified |
| Z-0578-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | Baxter Healthcare Corporation | 01/07/2022Open, Classified |
| Z-0577-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | Baxter Healthcare Corporation | 01/07/2022Open, Classified |
| Z-0576-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482ECleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | Baxter Healthcare Corporation | 01/07/2022Open, Classified |
| Z-0575-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | Baxter Healthcare Corporation | 01/07/2022Open, Classified |
| Z-0574-2022 Class II | Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de…Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | Baxter Healthcare Corporation | 01/07/2022Open, Classified |
| Z-0573-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJCleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | Baxter Healthcare Corporation | 01/07/2022Open, Classified |
| Z-0572-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | Baxter Healthcare Corporation | 01/07/2022Open, Classified |
| Z-0571-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | Baxter Healthcare Corporation | 01/07/2022Open, Classified |
| Z-0570-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | Baxter Healthcare Corporation | 01/07/2022Open, Classified |
| Z-2090-2021 Class II | 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius…Exposed to freezing temperatures due to refrigerated truck malfunctions | Fresenius Medical Care Holdings, Inc. | 04/28/2021Terminated |
| Z-2089-2021 Class II | The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that…Exposed to freezing temperatures due to refrigerated truck malfunctions | Fresenius Medical Care Holdings, Inc. | 04/28/2021Terminated |
| Z-2088-2021 Class II | The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a…Exposed to freezing temperatures due to refrigerated truck malfunctions | Fresenius Medical Care Holdings, Inc. | 04/28/2021Terminated |
| Z-2083-2021 Class II | The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used…Exposed to freezing temperatures due to refrigerated truck malfunctions | Fresenius Medical Care Holdings, Inc. | 04/28/2021Terminated |
| Z-0768-2021 Class II | MiniCap Extended Life PD Transfer SetPotential for no-flow and leaks under the twist clamp. | Baxter Healthcare Corporation | 11/10/2020Terminated |