Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 1,266 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infections.
What this means for you
Illness, injury, or structural failure has been reported. 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 and involves a risk of surgical site infection, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for hospitalization or significant injury).
Plain-English summary
Riverpoint Medical, LLC is recalling 1,266 units of Velosorb Fast Braided Absorbable Sutures, specifically the 3/0 Undyed 18" P-12 Cutting variety (Lot Number: 20060929FX). The product was distributed nationwide in the United States. The recall is classified as Class II by the FDA.
The recall is being issued because the surgical sutures are non-sterile. The use of these non-sterile sutures could compromise the sterile field during surgery, which increases the risk of a surgical site infection. The source text also notes that the defect may increase break strength retention.
Healthcare facilities and consumers who have this specific lot of sutures should stop using them immediately. They should contact Riverpoint Medical for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12 Cutting SV497G, UDI: 20884521149707 - 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 liga
- Manufacturer
- Riverpoint Medical, LLC
- Hazard
- Affected units
- 1,266
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: 20060929FX
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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