LeMaitre Vascular TCI System Recalled for Incorrect Expiration Date Labeling
LeMaitre Vascular is recalling 54 units of the Tumescent Catheter Inversion System because they were mislabeled with an incorrect expiration date.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging or documentation problems.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 54 units of the LeMaitre Vascular Tumescent Catheter Inversion (TCI) System, Catalog Number 7210023, Lot #61049252. The TCI System is intended to provide a system for the removal of an incompetent greater saphenous vein.
The recall was initiated because the affected units were mislabeled with an incorrect expiration date. The source text does not specify the correct expiration date or the nature of the labeling error beyond it being incorrect.
The affected units were distributed in California, Colorado, Kansas, Minnesota, Utah, Washington, and Wisconsin. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any illnesses or injuries associated with the use of these products.
The recalled product
- Product
- LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252
- Manufacturer
- LeMaitre Vascular, Inc.
- Hazard
- Affected units
- 54
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: 61049252 Exp. Date: 2016-06
Distribution
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