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Retrowash

INTERMARK MEDICAL INNOVATIONS LIMITED · Model RW35 · UDI-DI 05060485740001

KOA

510(k) clearances

Adverse events

Recalls

115

Facilities

Description

Retrowash On-Table Lavage/Bowel Washout Kit, 35mm version, for intra-operative washout of the colon in emergency obstructions. The 35mm version is for use where there is little or no bowel distension. After washout, the device facilitates on-table colonoscopy if desired. Sterile. Comprised of 1 x 35mm Handpiece Assembly with 1.6m waste tubing; 1.5m Giving Set; 1.0m Extension Set; 4 x Ties; 2 x 10l Cubitainer waste receptacles.

Recalls

Date	Firm	Reason
2020-04-01	Aesculap Implant Systems LLC	Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
2020-04-01	Aesculap Implant Systems LLC	Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
2019-04-10	Uromedica Inc.	Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT i
2017-05-01	Cook Inc.	COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti
2017-05-01	Cook Inc.	COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti
2017-05-01	Cook Inc.	COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti

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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.