Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 3,103 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. This defect could compromise the sterile field and increase the risk of surgical site infection.
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 (non-sterile surgical suture) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical risk of surgical site infection.
Plain-English summary
Riverpoint Medical, LLC is recalling 3,103 units of Velosorb Fast Braided Absorbable Sutures (Product Number: CV947, Lot Number: 20052816X). The affected products were distributed nationwide in the United States. These sutures are indicated for soft tissue approximation of the skin and mucosa where 7-10 days of wound support is required.
The recall was initiated because the surgical sutures are non-sterile. The use of non-sterile sutures could compromise the sterile field during a procedure, which may increase the risk of a surgical site infection. The source text also notes an increase in break strength retention.
Healthcare facilities and consumers who have these specific products should stop using them immediately. The recalling firm, Riverpoint Medical, LLC, is responsible for the recall. No specific dates or additional distribution details are provided in the source text.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21 Taper, Product Number: CV947, UDI: 20884521153056 - 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
- 3,103
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: 20052816X
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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