Recall Z-2319-2021 ยท BTR Tube, Tracheal (W/Wo Connector)
Teleflex Medical Europe Ltd
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
| 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 | 32410 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780900 | SLICK SET Polamedco, Inc., Jul 17, 1978 |