Z-2401-2021 Class II Terminated
FDA device recall Z-2401-2021 was initiated by Smiths Medical ASD Inc. on August 4, 2021 and is designated Class II. Reason for recall: The incorrect device is contained in the package. The recall status is terminated (terminated March 11, 2025). Affected quantity: 1,590 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 8, 2021
- Initiation Date
- August 4, 2021
- Termination Date
- March 11, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,590 units
Product Description
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 Pattern
International distribution was made to the countries of Canada, Japan, Indonesia, and Spain.
Code Information
Lot 4015424