The Recall Desk
HighFDA (Devices)·Z-0036-2021·Announced 2020-10-07

Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

Riverpoint Medical is recalling 1,272 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. This condition 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 medical device where the hazard is the potential for surgical site infection due to non-sterility, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Riverpoint Medical, LLC is recalling 1,272 units of Velosorb Fast Braided Absorbable Sutures (Lot Number: 20060203X). The affected product is the Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, identified by UDI 20884521151298. The sutures were distributed nationwide in the United States.

The recall is being issued because the surgical sutures are non-sterile. The use of non-sterile sutures could compromise the sterile field during a procedure, increase the risk of a surgical site infection, and increase break strength retention. The product is indicated for use in soft tissue approximation of the skin and mucosa where only 7-10 days of wound support is required, but it is not for use in ligation, ophthalmic, cardiovascular, or neurological procedures.

Healthcare facilities and consumers should stop using the affected sutures immediately. Users should contact Riverpoint Medical, LLC for further instructions on how to return or dispose of the product.

The recalled product

Product
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, UDI: 20884521151298 - 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
1,272

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: 20060203X

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 →