The Recall Desk
HighFDA (Devices)·Z-0025-2021·Announced 2020-10-07

Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

Riverpoint Medical is recalling 1,267 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

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 the hazard is the potential for surgical site infection, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Riverpoint Medical, LLC is recalling 1,267 units of Velosorb Fast Braided Absorbable Sutures, specifically the 4/0 Undyed 18" P-12 Cutting variety (Product Number: SV496G, UDI: 20884521149691). The affected lot number is 20052721FX. These sutures were distributed nationwide in the United States.

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 that the defect could increase break strength retention.

Healthcare facilities and consumers who have this specific product should stop using it immediately. The sutures are indicated for soft tissue approximation of the skin and mucosa where 7-10 days of wound support is required, but are not for use in ligation, ophthalmic, cardiovascular, or neurological procedures.

The recalled product

Product
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cutting, Product Number: SV496G, UDI: 20884521149691 - 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 no
Affected units
1,267

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: 20052721FX

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 →