Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 9,214 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a risk of surgical site infection (a significant injury risk) corresponds to a severity score of 4 (Severe).
Plain-English summary
Riverpoint Medical, LLC is recalling 9,214 units of Velosorb Fast Braided Absorbable Sutures (Lot Number: 20061715FX). The specific product affected is the Covidien Velosorb 3/0 Undyed 30" C-13 Cutting suture, identified by UDI 20884521151021. These sutures are indicated for soft tissue approximation of the skin and mucosa where 7-10 days of wound support is required, but are not intended for ligation, ophthalmic, cardiovascular, or neurological procedures.
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. The source text also notes an increase in break strength retention, though the primary safety concern is the lack of sterility.
The affected products were distributed nationwide in the United States. Healthcare facilities and consumers who have these specific sutures should stop using them immediately and contact Riverpoint Medical for instructions on return or disposal.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-13 Cutting SV2298, UDI: 20884521151021 - 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
- 9,214
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: 20061715FX
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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