Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling non-sterile Velosorb Fast Braided Absorbable Sutures because they may 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 (surgical site infection) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Riverpoint Medical, LLC is recalling 1,267 units of Velosorb Fast Braided Absorbable Sutures (Product Number: SV4893, Lot Number: 20052703FX). The affected product is a 6/0 undyed, 30-inch P-10 cutting suture indicated for soft tissue approximation of the skin and mucosa where 7-10 days of wound support is required.
The recall was initiated because the surgical sutures are non-sterile. The use of these non-sterile sutures could compromise the sterile field, increase the risk of a surgical site infection, and increase break strength retention. The affected units were distributed nationwide in the United States.
Healthcare providers and facilities should stop using the affected sutures and contact Riverpoint Medical for further instructions. Consumers are not expected to have this product in their homes, as it is a medical device intended for professional use.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 30" P-10 Cutting, Product Number: SV4893, UDI: 20884521151717 - 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 no
- Manufacturer
- Riverpoint Medical, LLC
- Affected units
- 1,267
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: 20052703FX
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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