Facility

Vantive Manufacturing Limited

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002806471
Establishment type	Manufacture Medical Device
Location	Foxford Road SWINFORD Mayo, IE F12 YK73
Registration status	Active · expires 2026
Parent company	Vantive US Healthcare LLC (owner-operator 9038727)
Brand names	Minicap Extended Life PD Transfer Sets; Locking Titanium Adapter for Peritoneal Dialysis Catheter and Locking Cap for Peritoneal Dialysis Catheter Adapter

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (1)

Set, Administration, For Peritoneal Dialysis, Disposable
Product code KDJ (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5630

Recalls & enforcement

Class IIOngoing2026-01-06
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class IIOngoing2025-08-28
Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may thin…
Class IIOngoing2025-07-28
Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted

FDA inspections (1)

NAI2017-01-26
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Vantive Manufacturing Limited (FEI 3002806471) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002806471-vantive-manufacturing-limited/

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