—#187587

Product

PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.

FDA product code: JOH — Tube Tracheostomy And Tube Cuff
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K041348
Affected lot / code info: Lot Number 4072715

Why it was recalled

One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

The firm initiated the recall by email on 05/14/2021. The notice requested the return of the units and distributors were directed to notify their customers.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: US Nationwide distribution in the states of PA, MI, MD, FL.

Timeline

Recall initiated: 2021-05-14
Terminated: 2023-06-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187587. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.