Endoscopic Irrigation/suction System

ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Velocity" Biopsy Valve, 25 units per box,

The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use.

Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC

Potential for failure of the pouch packaging seal at high altitudes.

Torrent" irrigation tubing.

The firm was notified by their customers that there was a water leakage from the white tubing connector.

STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve)

Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector)

Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction)

Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure