The Recall Desk
HighFDA (Devices)·Z-0038-2021·Announced 2020-10-07

Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

Riverpoint Medical is recalling 1,260 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a 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 (non-sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical risk without confirmed illness.

Plain-English summary

Riverpoint Medical, LLC is recalling 1,260 units of Velosorb Fast Braided Absorbable Sutures (Lot Number 20060205FX). The product is identified as Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295 with UDI 20884521177410. The recall was initiated because the surgical sutures are non-sterile.

The use of non-sterile sutures could compromise the sterile field during surgery, increase the risk of a surgical site infection, and increase break strength retention. The product is indicated for use in soft tissue approximation of the skin and mucosa where only 7-10 days of wound support is required, but is not for use in ligation, ophthalmic, cardiovascular, or neurological procedures.

The affected units were distributed nationwide in the United States. Healthcare facilities and consumers should stop using the affected product and contact Riverpoint Medical for further instructions.

The recalled product

Product
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295, UDI: 20884521177410 - 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 ligation, o
Affected units
1,260

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: 20060205FX

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 →