The Recall Desk
HighFDA (Devices)·Z-0024-2021·Announced 2020-10-07

Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

Riverpoint Medical is recalling non-sterile Velosorb sutures that could 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 medical device where the hazard (surgical site infection) is a significant risk of harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.

Plain-English summary

Riverpoint Medical, LLC is recalling 6,150 units of Velosorb Fast Braided Absorbable Suture, specifically the 4/0 Undyed 30" CV-25 Taper (Product Number CV3100, UDI 20884521150901). The affected units are from Lot Number 20052720X and were distributed nationwide in the United States.

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.

Healthcare providers and facilities should stop using the affected sutures and contact Riverpoint Medical for instructions on how to return the product.

The recalled product

Product
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" CV-25 Taper, Product Number: CV3100, UDI: 20884521150901 - 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
6,150

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: 20052720X

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 →