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Proctowash

INTERMARK MEDICAL INNOVATIONS LIMITED · Model PR01 · UDI-DI 05060485740025

FGM

510(k) clearances

Adverse events (1 deaths)

Recalls

104

Facilities

Description

Proctowash Rectal Stump Washout Kit for elimination of exfoliated tumour cells from the rectal stump in colorectal cancer procedures. Rectal washout for intra-operative prepping of the rectum whenever required. Non-sterile. Comprised of 1 x Handset/probe with flexible atraumatic tip, 1 x 2.5m Giving Set, 1 x 0.8m Waste Tubing, 1 x 3l Cubitainer waste receptacle.

Recalls

Date	Firm	Reason
2004-02-06	Medtronic Gastroenterology / Urology	The product's rear panel label could smear during use causing the serial number to be unreadible. This has the remote possibility of resulting in patient data from diagnostic test

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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.