Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 1,248 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a 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 sutures) where injury has not yet been reported, fitting the 'High' severity criteria for potential surgical site infections.
Plain-English summary
Riverpoint Medical, LLC is recalling 1,248 units of Velosorb Fast Braided Absorbable Sutures, specifically the 3/0 Undyed 30" SC-1 product (Product Number: SV2239, UDI: 20884521151779). The affected units are from Lot Number 20052701X and were distributed nationwide in the United States.
The recall was initiated because the surgical sutures are non-sterile. The FDA notes that using these non-sterile sutures could compromise the sterile field during a procedure, which increases the risk of a surgical site infection. The source text also states that use could increase break strength retention.
Healthcare facilities and consumers who have these specific sutures should stop using them immediately and contact Riverpoint Medical, LLC for further instructions on return or disposal. The product is indicated for 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.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" SC-1, Product Number: SV2239, UDI: 20884521151779 - 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
- Hazard
- Affected units
- 1,248
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: 20052701X
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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