Facility

SIMPLIVIA HEALTHCARE LTD.

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3002807615
Establishment type	Manufacture Medical Device
Location	NORTH IND. ZONE P.O.BOX 888 KIRYAT SHMONA Northern, IL 11018
Registration status	Active · expires 2026
Parent company	SIMPLIVIA HEALTHCARE LTD. (owner-operator 9001925)
Brand names	OnGuard®2 Female Luer Lock Adaptor

Activity by year

Recalls (1)

Devices registered here (1)

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Product code ONB (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5440

Recalls & enforcement

Class IIOngoing2022-03-08
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.

All facilities operated by SIMPLIVIA HEALTHCARE LTD.

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. “SIMPLIVIA HEALTHCARE LTD. (FEI 3002807615) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807615-simplivia-healthcare-ltd/

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