Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 1,886 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infections.
What this means for you
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 the hazard is theoretical (increased risk of infection) and no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Riverpoint Medical, LLC is recalling 1,886 units of Velosorb Fast Braided Absorbable Sutures (Product Number: SVP2294, UDI: 20884521177403). The affected lot number is 20052017FX. The product was distributed nationwide in the United States.
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 is indicated for use in soft tissue approximation of the skin and mucosa where only 7-10 days of wound support is required, but is not for use in ligation, ophthalmic, cardiovascular, or neurological procedures.
Healthcare facilities and consumers who have this product should stop using it and contact Riverpoint Medical, LLC for further instructions.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product Number: SVP2294, UDI: 20884521177403 - 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 for u
- Manufacturer
- Riverpoint Medical, LLC
- Category
- Medical Device — Surgical Suture
- Hazard
- Affected units
- 1,886
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: 20052017FX
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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