Recall Z-0799-2015 ยท BTR Tube, Tracheal (W/Wo Connector)
Teleflex Medical
Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.
| Date | Dec 12, 2014 (initiated Nov 12, 2014) |
| Status | Terminated |
| Reason | Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube. |
| Root cause | Process control |
| Action | Consignees were notified by an Urgent Medical Device Recall Notification letter on 11/12/2014. The letter identified the affected product, as well as, the reason for the recall. Customers are instructed to immediately discontinue use of and quarantine any affected product. They are also instructed to complete and fax or e-mail the enclosed Recall Acknowledgement Form regardless of whether they have affected product in stock or not. Upon receipt of the form, a customer service representative will contact customers to provide an RGA number, as well as, instructions for the return of the prod |
| Quantity | 14,000 units |
| Distribution | Worldwide Distribution -- U.S., Belgium, Canada, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822082 | SHERIDAN/HVT,CF, UNCUFFED Sheridan Catheter Corp., Aug 10, 1982 |