Riverpoint Recalls Vilet Surgical Suture Due to Labeling Error
Riverpoint Medical is recalling 1,932 pieces of Vilet surgical suture because the label incorrectly states the suture is undyed when it is actually violet.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a minor labeling error regarding color identification with no reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Riverpoint Medical, LLC is recalling 1,932 pieces of Polyglycolic-Lactic Acid (PGLA) Absorbable Surgical Suture, branded as Vilet. The specific lot number is 120716-01. The product is indicated for general soft tissue approximation and ligation, including ophthalmic procedures, but is not intended for cardiovascular or neurological tissues.
The recall was initiated because the product label incorrectly indicates that the suture is undyed, whereas the suture is actually violet in color. This labeling discrepancy does not appear to affect the safety or efficacy of the suture itself, but it may cause confusion for medical professionals relying on the label for identification.
The affected products were distributed in the United States to the states of Arizona, Florida, and Texas. Medical facilities and distributors should stop using the affected sutures and contact Riverpoint Medical for instructions on return or disposal.
The recalled product
- Product
- Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in…
- Manufacturer
- Riverpoint Medical, LLC
- Category
- Medical Device — Surgical Suture
- Hazard
- Affected units
- 1,932
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 120716-01
Distribution
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