The Recall Desk
SevereFDA (Devices)·Z-0045-2021·Announced 2020-10-07

Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

Riverpoint Medical is recalling 1,253 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

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a non-sterile medical device used in surgery, which poses a significant risk of surgical site infection, meeting the criteria for a Severe rating.

Plain-English summary

Riverpoint Medical, LLC is recalling 1,253 units of Velosorb Fast Braided Absorbable Sutures, specifically the 2/0 Undyed 30" GS-20 CV9975G model (Lot Number: 20060930X). The product was 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 surgery. This defect increases the risk of a surgical site infection and may affect break strength retention. 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.

Healthcare providers and facilities that have received this product should stop using it immediately. They should contact Riverpoint Medical, LLC for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G, UDI: 20884521149585 - 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,
Affected units
1,253

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: 20060930X

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 →