Recalls / —
—#188613
Product
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
- FDA product code
- OGK — Orotracheal Intubation Guide Kit
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- Affected lot / code info
- Lot 4015424
Why it was recalled
The incorrect device is contained in the package.
Root cause (FDA determination)
Employee error
Action the firm took
The letter dated 8/4/2021 was issued 8/4/2021 via tracked mail and requested return of the product.
Recalling firm
- Firm
- Smiths Medical ASD Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- Distribution pattern
- International distribution was made to the countries of Canada, Japan, Indonesia, and Spain.
Timeline
- Recall initiated
- 2021-08-04
- Terminated
- 2025-03-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #188613. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.