Recall Z-1078-2015 ยท BTR Tube, Tracheal (W/Wo Connector)
Teleflex Medical
Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
| Date | Feb 10, 2015 (initiated Jan 9, 2015) |
| Status | Terminated |
| Reason | Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube. |
| Root cause | Labeling mix-ups |
| Action | Teleflex Medical sent an " Urgent Medical Device Recall Notification" dated January 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to immediately discontinue use and quarantine any of the affected products, return the product and to complete the enclosed Recall Acknowledgement Form even if they do not have the affected product in stock. Distributors were instructed to communicate the recall to any of their customers who may have received product included within the scope of the recall. H |
| Quantity | 300 units |
| Distribution | Worldwide Distribution - US Distribution to the states of FL, GA, IL, KY, MA, MI, MO, MS, OH, TX, WA and WV., and to the countries of Canada and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822082 | SHERIDAN/HVT,CF, UNCUFFED Sheridan Catheter Corp., Aug 10, 1982 |