Recall Z-0804-2019 ยท KTI Bronchoscope Accessory
Richard Wolf GmbH
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 pathways, in conjunction with endoscopic accessories. The bronchoscopes can also be used endoscopically t
| Date | Oct 17, 2018 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On about 09/24/2018, Richard Wolf GmbH sent Urgent Safety Information notices to international consignees. Customers in the USA were sent the "Urgent Safety Information" notice on about 10/17/2018. Customers were instructed to check current stock on hand for affected Bronchoscope Tubes, complete and return the attached response form, ensure all appropriate personnel at the facility are notified of the recall, ensure the recall information is observed in your respective institution until all internal measures have been completed, notify Richard Wolf of any adverse events, and return all affec |
| Quantity | 873 units worldwide (468 units within the US) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.