Set, Administration, For Peritoneal Dialysis, Disposable
Gastroenterology, Urology · 21 CFR 876.5630
Recent MDR events
72,142 adverse event reports on file
- MiniCapJul 31, 2026MalfunctionVantive Us Healthcare Llc2314912-2026-00472
- Set, Administration, For Peritoneal Dialysis, DisposableJul 31, 2026InjuryVantive Us Healthcare Llc3038195011-2026-00786
- Set, Administration, For Peritoneal Dialysis, DisposableJul 31, 2026InjuryVantive Us Healthcare Llc3038195011-2026-00787
- Set, Administration, For Peritoneal Dialysis, DisposableJul 31, 2026InjuryVantive Us Healthcare Llc3038195011-2026-00788
- Locking Titanium Adapter for Peritoneal Dialysis CatheterJul 30, 2026MalfunctionVantive Us Healthcare Llc9612168-2026-00041
- MiniCap Transfer SetJul 30, 2026MalfunctionVantive Us Healthcare Llc2314912-2026-00468
- Set, Administration, For Peritoneal Dialysis, DisposableJul 30, 2026InjuryVantive Us Healthcare Llc3038195011-2026-00780
- Set, Administration, For Peritoneal Dialysis, DisposableJul 30, 2026InjuryVantive Us Healthcare Llc3038195011-2026-00781
- Set, Administration, For Peritoneal Dialysis, DisposableJul 30, 2026InjuryVantive Us Healthcare Llc3038195011-2026-00782
- Set, Administration, For Peritoneal Dialysis, DisposableJul 30, 2026InjuryVantive Us Healthcare Llc3038195011-2026-00783
Event type breakdown
Recalls
61 recall events for this product code
- Baxter Healthcare CorporationOpen, ClassifiedNov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Z-0559-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedNov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Z-0560-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedNov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Z-0561-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedNov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Z-0562-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedNov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Z-0563-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedNov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Z-0564-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedNov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Z-0565-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedNov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Z-0566-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedNov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Z-0567-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedNov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Z-0568-2025 · View FDA record ↗
Registered firms
83 firms currently registered for this product code
Fresenius Medical Care Renal Therapies Group, Llc
Waltham, MA, US
Erika De Reynosa, S.a. De C.v.
CD, REYNOSA Tamaulipas, MX
Vantive Us Healthcare Llc
Deerfield, IL, US
Sterigenics Radiation Technologies Canada, Inc
PORT COQUITLAM British Columbia, CA
Sterigenics Us Llc
Fort Worth, TX, US
Gambro Uf Solutions Llc
Plymouth, MN, US
Sterigenics Us Llc
Grand Prairie, TX, US
Vantive Us Healthcare Llc
MOUNTAIN HOME, AR, US
Erika De Reynosa, S.a. De C.v.
CD, REYNOSA Tamaulipas, MX
Byonyks Pvt Ltd
Lahore Punjab, PK
Isomedix Operations Inc.
GRAND PRAIRIE, TX, US
510(k) clearances
113 clearances for this product code
- Fresenius Medical Care Renal Therapies Group, LLCApr 3, 2025
K250404 · staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch
- Baxter HealthcareMar 12, 2024
K231849 · MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
- Baxter Healthcare CorporationMar 18, 2022
K214016 · 15L Cycler Drainage Bag
- Baxter HealthcareOct 25, 2019
K192705 · MiniCap Extended Life PD Transfer Sets
- Fresenius Medical Care Renal Therapies Group, LLCMay 21, 2018
K173593 · staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch
- Fresenius Medical Care Renal Therapies Group, LLCFeb 14, 2018
K173651 · Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
- Fresenius Medical Care Renal Therapies Group, LLCJan 24, 2018
K173363 · Cycler Drain Bag Set
- Puracath Medical, Inc.Jan 20, 2016
K151620 · Firefly Peritoneal Dialysis Connector Disinfection System