FDA recall Z-2401-2021

Smiths Medical ASD Inc. · Class II · device

Product

smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.

Reason for recall

The incorrect device is contained in the package.

Distribution

International distribution was made to the countries of Canada, Japan, Indonesia, and Spain.

Key facts

Status
Terminated
Initiation date
2021-08-04
Report date
2021-09-08
Termination date
2025-03-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2401-2021