Recall Z-1231-2014— Teleflex Medical
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical, initiated 2014-02-28, terminated 2016-09-28. It names one FDA 510(k) clearance: K951091. Product: Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobronchial tube allows ventilation and selective inflation or deflation of either lung.. Reason: The product may fail to achieve seal of right lung due to the cuff inflating to one side.
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-28
- Terminated
- 2016-09-28
- Firm location
- Durham, NC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobronchial tube allows ventilation and selective inflation or deflation of either lung.
Reason for recall
The product may fail to achieve seal of right lung due to the cuff inflating to one side
Data sourced from openFDA. This site is unofficial and independent of the FDA.