The Recall Desk
HighFDA (Devices)·Z-0016-2021·Announced 2020-10-07

Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

Riverpoint Medical is recalling 3,110 units of non-sterile Velosorb sutures because they may compromise the sterile field and increase infection risk.

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, fitting the High severity criteria.

Plain-English summary

Riverpoint Medical, LLC is recalling 3,110 units of Velosorb Fast Braided Absorbable Sutures (Product Number: SV6830, Lot Number: 20051814FX). The affected product is a 3/0 undyed 18-inch P-14 cutting suture indicated for soft tissue approximation of the skin and mucosa.

The recall was initiated because the surgical sutures are non-sterile. The use of non-sterile sutures could compromise the sterile field, increase the risk of a surgical site infection, and increase break strength retention. The product was distributed nationwide in the United States.

Healthcare providers and facilities should stop using the affected sutures immediately. Consumers who have purchased this product should contact their healthcare provider or the recalling firm for instructions on return or replacement.

The recalled product

Product
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20884521152349 - 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
Affected units
3,110

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: 20051814FX

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.

See all 40 products in this recall →