Recall Z-2401-2021 ยท OGK Orotracheal Intubation Guide Kit
Smiths Medical ASD Inc.
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
| Date | Aug 4, 2021 |
| Status | Terminated |
| Reason | The incorrect device is contained in the package. |
| Root cause | Employee error |
| Action | The letter dated 8/4/2021 was issued 8/4/2021 via tracked mail and requested return of the product. |
| Quantity | 1,590 units |
| Distribution | International distribution was made to the countries of Canada, Japan, Indonesia, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.