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Spike Adapter

ORIGEN BIOMEDICAL, INC. · Model 40-S-V-SMM · UDI-DI 10816203020632

KJG Prescription
1
510(k) clearances
30
Adverse events
1
Recalls
35
Facilities

Description

One spike to a needle-free valve to one spike and two male luers with 40cm tubing and roller clamps

Recalls

DateFirmReason
2023-12-19OriGen Biomedical, Inc.Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulte

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.