Riverpoint Recalls Non-Sterile Velosorb Fast Braided Absorbable Sutures
Riverpoint Medical is recalling 1,270 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a 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 medical device) 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 1,270 units of Velosorb Fast Braided Absorbable Sutures (Product Number: SV32, UDI: 20884521153117). The affected lot number is 20052702FX. 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 use could increase break strength retention.
Healthcare facilities and consumers should stop using the affected sutures immediately. The product is indicated for soft tissue approximation of the skin and mucosa where only 7-10 days of wound support is required, but it is not for use in ligation, ophthalmic, cardiovascular, or neurological procedures.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 VL 18" P-10, Product Number: SV32, UDI: 20884521153117 - 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 use in…
- Manufacturer
- Riverpoint Medical, LLC
- Hazard
- Affected units
- 1,270
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: 20052702FX
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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