The Recall Desk
HighFDA (Devices)·Z-0027-2021·Announced 2020-10-07

Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

Riverpoint Medical is recalling 3,103 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. This defect 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 risk-of-harm product (non-sterile surgical suture) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical risk of surgical site infection.

Plain-English summary

Riverpoint Medical, LLC is recalling 3,103 units of Velosorb Fast Braided Absorbable Sutures (Product Number: CV947, Lot Number: 20052816X). The affected products were distributed nationwide in the United States. These sutures are 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 non-sterile sutures could compromise the sterile field during a procedure, which may increase the risk of a surgical site infection. The source text also notes an increase in break strength retention.

Healthcare facilities and consumers who have these specific products should stop using them immediately. The recalling firm, Riverpoint Medical, LLC, is responsible for the recall. No specific dates or additional distribution details are provided in the source text.

The recalled product

Product
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21 Taper, Product Number: CV947, UDI: 20884521153056 - 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 fo
Affected units
3,103

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: 20052816X

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 →