Recall Z-1993-2021— Smiths Medical ASD Inc.

Name: FDA recall Z-1993-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-14

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2021-05-14, terminated 2023-06-09. It names one FDA 510(k) clearance: K041348. 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.. Reason: 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..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-05-14
Terminated: 2023-06-09
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K041348 — PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRASmiths Medical·cleared 2004-07-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.