Recall Z-2320-2021 ยท BTR Tube, Tracheal (W/Wo Connector)
Teleflex Medical Europe Ltd
RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
| 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 | 155030 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 |