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Injection Spike

ORIGEN BIOMEDICAL, INC. · Model IBS-X · UDI-DI 10816203020113

KJG Prescription
1
510(k) clearances
29
Adverse events
1
Recalls
35
Facilities

Description

DMSO-Resistant Bag Spike with non- ahdered needle injection port, case of 50

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.