Recall Z-1891-2009 ยท BTR Tube, Tracheal (W/Wo Connector)
Teleflex Medical
Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex Medical Ltd, Research Triangle Park, NC 27709 Used for oral or nasal intubation for airway management.
| Date | Aug 26, 2009 (initiated Jul 6, 2009) |
| Status | Terminated |
| Reason | The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings. |
| Root cause | Process control |
| Action | Consignees were notified by an Urgent Medical Device Recall letter on/about 07/06/2009. They were instructed to discontinue use of and return any of the recalled product to Teleflex Medical. Distributors were advised to forward the letter to their consignees to retrieve relevant product from those locations. A Recall Acknowledgement Form was attached to be returned to Teleflex Medical. Replacement product or credit will be provided to the consignee. |
| Quantity | 1160 total |
| Distribution | Worldwide Distribution -- USA, including states of CA, FL, IL, KY, MA, NC, NM, NJ, OH, PA, RI, TN, TX, UT, VA, WA, and WI and countries of France 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 |