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Tube Organiser

PURPLE SURGICAL INTERNATIONAL LIMITED · Model PS5100 · UDI-DI 05051223004424

BYX Prescription

510(k) clearances

518

Adverse events (14 deaths)

Recalls

232

Facilities

Description

The Tube Organiser is used to secure and organize tubing, cables & leads. The use of the Tube organiser helps ensure the surgical work area is kept free of the potential of trip and entanglement hazards associated with loose tubing during procedures, and aids prevention of kinking and possible occlusion.

Recalls

Date	Firm	Reason
2018-08-10	A M Systems Inc	Some of the Disposable Smooth Interior Tubing may pull apart when stretched.

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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.