Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 3,110 units of non-sterile Velosorb sutures because they may compromise the sterile field and increase infection risk.
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: The recall involves a risk-of-harm product (surgical site infection) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Riverpoint Medical, LLC is recalling 3,110 units of Velosorb Fast Braided Absorbable Sutures (Product Number: SV6830, Lot Number: 20051814FX). The affected product is a 3/0 undyed 18-inch P-14 cutting suture indicated for soft tissue approximation of the skin and mucosa.
The recall was initiated because the surgical sutures are non-sterile. The use of non-sterile sutures could compromise the sterile field, increase the risk of a surgical site infection, and increase break strength retention. The product was distributed nationwide in the United States.
Healthcare providers and facilities should stop using the affected sutures immediately. Consumers who have purchased this product should contact their healthcare provider or the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20884521152349 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not…
- Manufacturer
- Riverpoint Medical, LLC
- Hazard
- Affected units
- 3,110
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: 20051814FX
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 40 recalled by Riverpoint Medical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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