Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 2,499 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 infection.
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 are reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Riverpoint Medical, LLC is recalling 2,499 units of Velosorb Fast Braided Absorbable Sutures, specifically the 4/0 Undyed 18" P-12 Cut (Product Number: SV496, UDI: 20884521184258). The affected lot number is 20060116FX. 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 during a procedure, which increases the risk of a surgical site infection. The source text also notes that the defect may increase break strength retention.
Healthcare facilities and consumers who have this specific lot of sutures should stop using them immediately. The sutures are indicated for soft tissue approximation of the skin and mucosa where 7-10 days of wound support is required, but are not for use in ligation, ophthalmic, cardiovascular, or neurological procedures.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cut, Product Number: SV496, UDI: 20884521184258 - 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
- Manufacturer
- Riverpoint Medical, LLC
- Hazard
- Affected units
- 2,499
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: 20060116FX
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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