Percutaneous Dilation Tracheostomy Kit Recalled for Incorrect Size Labeling
One lot of PORTEX ULTRperc Percutaneous Dilation Tracheostomy Kit (Lot 4072715) was incorrectly labeled as 7.0mm when it is 9.0mm. The 40 units were distributed in Pennsylvania, Michigan, Maryland, and Florida.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device used in surgical procedures. While no illnesses or injuries have been reported, the size mislabeling (7.0mm vs 9.0mm) presents a risk of harm if the device is used without confirming the actual specifications, meeting the rubric criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling one lot of the PORTEX ULTRperc Percutaneous Dilation Tracheostomy Kit (REF 100/596/090). The recalled lot number is 4072715. Units in this lot were manufactured and labeled incorrectly: they were labeled as 7.0mm inner diameter (ID) kits but are actually 9.0mm.
Approximately 40 units of this kit were distributed nationwide to hospitals and medical facilities in Pennsylvania, Michigan, Maryland, and Florida. The kit is intended for use in controlled settings such as Intensive Care Units or operating rooms under the supervision of trained personnel.
The size discrepancy between the label and the actual product could result in incorrect sizing selection during the procedure if the labeling error is not detected. Healthcare facilities that received this lot should verify the actual kit specifications and contact Smiths Medical ASD Inc. or the FDA if they have concerns.
The recalled product
- 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.
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 4072715
Distribution
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