Z-1993-2021 Class II Terminated
FDA device recall Z-1993-2021 was initiated by Smiths Medical ASD Inc. on May 14, 2021 and is designated Class II. 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. The recall status is terminated (terminated June 9, 2023). Affected quantity: 40 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 7, 2021
- Initiation Date
- May 14, 2021
- Termination Date
- June 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 units
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.
Distribution Pattern
US Nationwide distribution in the states of PA, MI, MD, FL.
Code Information
Lot Number 4072715