IDEV Technologies Recalls SUPERA VERITAS Stent Due to Outer Labeling Error
IDEV Technologies is recalling three SUPERA VERITAS stents because of an error on the outer labeling. The inner label was correct.
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 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 for a packaging/labeling error where the inner label was correct, fitting the rubric criteria for cosmetic defects or packaging-only problems.
Plain-English summary
IDEV Technologies, Inc. is recalling three units of the SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. This device is indicated for the palliative treatment of biliary strictures produced by malignant neoplasms.
The recall was initiated due to an error on the outer labeling of the device. The source text notes that the inner label was correct.
The affected units are identified by Model Number S-05-100-120-G3 and Lot Number 01049037. These devices were distributed nationwide to the states of Florida, New York, and Pennsylvania.
The recalled product
- Product
- IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms
- Manufacturer
- IDEV Technologies, Inc.
- Category
- Medical Device — Biliary Stent
- Hazard
- Affected units
- 3
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 (2)
- Model Number: S-05-100-120-G3
- Lot Number 01049037
Distribution
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