Recall Z-2321-2021 ยท BTR Tube, Tracheal (W/Wo Connector)
Teleflex Medical Europe Ltd
RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100
| Date | Jul 16, 2021 |
| Status | Terminated |
| Reason | The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. |
| Root cause | Process control |
| Action | The firm initiated the recall by letter on 07/16/2021. The letter explained the issue and requested the return of the product. Distributors were directed to notify their customers. |
| Quantity | 2610 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961837 | RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY Rusch Intl., Aug 16, 1996 |