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PVC Transfer Bag

ORIGEN BIOMEDICAL, INC. · Model 10-200-2 · UDI-DI 10816203023282

KSR Prescription

510(k) clearances

617

Adverse events (8 deaths)

Recalls

Facilities

Description

Two 200ml PVC processing bag, with a male luer, a female luer, a needle-free injection port and a spike port

Recalls

Date	Firm	Reason
2012-01-20	DeRoyal Industries Inc	Device's needle may become dislodged from the cup during shipment or during use.
2012-01-20	DeRoyal Industries Inc	Device's needle may become dislodged from the cup during shipment or during use.
2006-06-21	Becton Dickinson & Company	Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.
2005-12-01	Becton Dickinson & Company	Cracked finger grip luer adapter components on the Push Button Blood Collection Set.

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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.