Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 1,242 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 medical device where the hazard (surgical site infection) is a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Riverpoint Medical, LLC is recalling 1,242 units of Velosorb Fast Braided Absorbable Sutures, specifically the 4/0 Undyed 30" P-12 Cutting model (SV426). The affected products are identified by Lot Number 20060813FX and UDI 20884521151731. These sutures were 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 surgery, which increases the risk of a surgical site infection. Additionally, the source text notes that use could increase break strength retention.
Healthcare facilities and consumers who have these specific sutures should stop using them immediately. The sutures are indicated for soft tissue approximation of the skin and mucosa where only 7-10 days of wound support is required, but they should not be used in ligation, ophthalmic, cardiovascular, or neurological procedures.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - 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
- 1,242
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: 20060813FX
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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