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Terminated

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 Recall Z-1993-2021 · Posted None

Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeJOH
Date Initiated2021-05-14
Date Terminated2023-06-09
Product Quantity40 units

Reason for Recall

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.

Firm Action

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.

Root Cause

Labeling mix-ups

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041348PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRASmiths Medical · 2004-07-13

Official Source

View FDA Recall →

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

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