FDA Device recall Z-1993-2021
PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as…
- FDA Device
- Class II
- terminated
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class II recall of PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as… by Smiths Medical Asd, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1993-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-14 |
| Published | 2021-07-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
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.
Identifiers
| code_info | Lot Number 4072715 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1993-2021%22
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