Richard Wolf Bronchoscope Tubes Recalled for Potential Bonding Defects

Plain-English summary

Richard Wolf GmbH is recalling 873 units of Bronchoscope Tubes, Model Texas, worldwide, including 468 units in the United States. The recall is due to a potential deficiency where non-functionally relevant bonding points or cemented areas of the tubes may loosen.

The affected devices are reusable bronchoscopes intended for the investigation, diagnosis, and therapy of pathological changes in the tracheobronchial respiratory pathways. They are also used for the removal of foreign bodies and to allow the insertion of auxiliary instruments. The recall covers all lot numbers manufactured from October 30, 2006, to August 15, 2018.

The devices were distributed in the US states of Pennsylvania, Maryland, and New York, as well as in Bangladesh, Canada, China, France, Germany, India, Italy, Jordan, the Netherlands, Poland, Russia, Spain, Thailand, and Turkey. Users should stop using the affected devices and contact the manufacturer for instructions on return or replacement.

The recalled product

Product

Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchi

Manufacturer

Richard Wolf GmbH

Category

Medical Device — Endoscopy

Hazard

• structural-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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