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Locking Titanium Adapter for Peritoneal Dialysis Catheter 5C4129

by Vantive US Healthcare, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

13 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07332414207946 UDI-DI Date23 Sep 2025ListedStatusListed GUDID: in commercial distribution

Recalls

13 recalls · 13 ongoing · FDA

    • Ongoing Z-0559-2025 FDA Class II initiated 23 Oct 2024

    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.

    • Ongoing Z-0373-2025 FDA Class I initiated 21 Oct 2024

    Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

  • 11 recalls, same reason

    • Ongoing Z-0580-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0576-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0579-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0574-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0571-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0570-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0578-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0577-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0575-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0572-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0573-2022 FDA Class II initiated 7 Jan 2022

    Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Locking Titanium Adapter for Peritoneal Dialysis Catheter
Generic Name
Peritoneal dialysis catheter adaptor, single-use
Model / Ref / Catalog
5C4129
Primary DI / UDI-DI
07332414207946
510(k) Number
FDA Product Code
KDJ
GMDN Term
Peritoneal dialysis catheter adaptor, single-use
Device Class
Class II
Regulation Number
876.5630
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K152675)

Other devices from Vantive US Healthcare, LLC

See all devices from Vantive US Healthcare, LLC →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No