Facility

Vantive Manufacturing Pte. Ltd.

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)	3002806460
Establishment type	Sterilize Medical Device for Another Party (Contract Sterilizer)
Location	2 WOODLANDS INDUSTRIAL PARK D SINGAPORE Central Singapore, SG 73777
Registration status	Active · expires 2026
Parent company	Vantive US Healthcare LLC (owner-operator 9038727)
Brand names	Needle, Hypodermic, Single Lumen

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (1)

Needle, Hypodermic, Single Lumen
Product code FMI (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5570

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)

NAI2017-04-13
No Action Indicated · Compliance: 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 Pte. Ltd. (FEI 3002806460) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002806460-vantive-manufacturing-pte-ltd/

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