Recall Z-1231-2014 ยท BTS Tube, Bronchial (W/Wo Connector)
Teleflex Medical
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.
| Date | Mar 19, 2014 (initiated Feb 28, 2014) |
| Status | Terminated |
| Reason | The product may fail to achieve seal of right lung due to the cuff inflating to one side |
| Root cause | Device Design |
| Action | Teleflex sent a Urgent Medical Device Recall Notification dated February 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service repres |
| Quantity | 63,568 ea. |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and the states of AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV and WI,and the countries of United Arab Emirates, Aus |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951091 | RUSCH ENDOBRONCHIAL TUBE SETS Rusch Intl., Jun 8, 1995 |