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Terminated

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

FDA Recall Z-2401-2021 · Posted None

Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeOGK
Date Initiated2021-08-04
Date Terminated2025-03-11
Product Quantity1,590 units

Reason for Recall

The incorrect device is contained in the package.

Firm Action

The letter dated 8/4/2021 was issued 8/4/2021 via tracked mail and requested return of the product.

Root Cause

Employee error

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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