Recall Z-1763-2019 ยท BTR Tube, Tracheal (W/Wo Connector)
Teleflex Medical
Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage: Tracheal tube/airway management
| Date | Jun 19, 2019 (initiated May 24, 2019) |
| Status | Terminated |
| Reason | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube. |
| Root cause | Process control |
| Action | Teleflex sent an Urgent Medical Device Recall letter dated May 24, 2019 to customers. The letter identified the affected product, problem and actions to be taken. The letter directed customers to discontinue use, quarantine the product, and contact Teleflex for return of the product. Distributors were directed to notify their customers and request the customer return the recalled products to them for consolidation and subsequent return to Teleflex.. For questions contact your local sales representative or Customer Service at 1-866-396-2111 |
| Quantity | 14357 |
| Distribution | Worldwide - US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822082 | SHERIDAN/HVT,CF, UNCUFFED Sheridan Catheter Corp., Aug 10, 1982 |