The Recall Desk
HighFDA (Devices)·Z-0017-2021·Announced 2020-10-07

Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

Riverpoint Medical is recalling 1,258 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 sutures) where the hazard is the potential for surgical site infection, but the source text does not report any actual illnesses or injuries, fitting the criteria for a High severity score.

Plain-English summary

Riverpoint Medical, LLC is recalling 1,258 units of Velosorb Fast Braided Absorbable Sutures, specifically the 4/0 Undyed 18" P-24 model (Product Number: SV9911G, UDI: 20884521149776). The affected units are identified by Lot Number 20051815FX 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 during a procedure, which increases the risk of a surgical site infection. Additionally, the source text notes that use could increase break strength retention.

Healthcare facilities and consumers who have these specific sutures should stop using them immediately and contact Riverpoint Medical for further instructions or a return. The product is indicated for soft tissue approximation of the skin and mucosa where 7-10 days of wound support is required, but is 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-24, Product Number: SV9911G, UDI: 20884521149776 - 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 u
Affected units
1,258

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: 20051815FX

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 →