Recall Z-2412-2015 ยท BTS Tube, Bronchial (W/Wo Connector)
Teleflex, Inc.
Tracheopart Set (Left), Sterile
| Date | Aug 18, 2015 (initiated Nov 21, 2014) |
| Status | Terminated |
| Reason | Customer complaints reporting that the cobb connector detached from the main connector prior to use. |
| Root cause | Other |
| Action | Recall letters were sent on 11/21/2014 to consignees requesting them to discontinue use and quarantine the products. The letter includes a reply form to be returned. The letter to the distributors requested a sub-recall, and included a recall letter to be sent to their accounts. |
| Distribution | AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, Trinidad & Tobago |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951091 | RUSCH ENDOBRONCHIAL TUBE SETS Rusch Intl., Jun 8, 1995 |