The Recall Desk
SevereFDA (Devices)·Z-0031-2021·Announced 2020-10-07

Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

Riverpoint Medical is recalling 1,264 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a 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 and involves a risk of surgical site infection, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for hospitalization or significant injury).

Plain-English summary

Riverpoint Medical, LLC is recalling 1,264 units of Velosorb Fast Braided Absorbable Sutures (Product Number: CV2293, Lot Number: 20060118X). The affected product is the Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting suture, indicated for soft tissue approximation of the skin and mucosa.

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. The product was distributed nationwide in the United States.

This recall is classified as Class II by the FDA. Healthcare facilities and consumers should stop using the affected sutures and contact Riverpoint Medical for further instructions.

The recalled product

Product
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, Product Number: CV2293, UDI: 20884521151588 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required,
Affected units
1,264

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: 20060118X

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 →