Product Wiki · Recalls · U.S. FDA — Device Enforcement

Richard Wolf Bronchoscope Tubes, Model Texas — recall Z-0804-2019

U.S. FDA — Device Enforcement · Germany · 2018-10-17 · Class II

As described by U.S. FDA — Device Enforcement: 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 tracheobronchial respiratory pathw

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0804-2019
Date of alert
2018-10-17
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Richard Wolf GmbH
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide distribution - US Nationwide in the states of PA, MD, NY, and countries of Bangladesh, Canada, China, France, Germany, India, Italy, Jordan, Netherlands, Poland, Russia, Spain, Thailand, Turkey.
Reported risk: There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes may loosen.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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