Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 1,236 units of non-sterile Velosorb sutures due to risks of surgical site infection and compromised sterile fields.
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 injury has not yet been reported, fitting the 'High' severity criteria for theoretical risk of surgical site infection.
Plain-English summary
Riverpoint Medical, LLC is recalling 1,236 units of Velosorb Fast Braided Absorbable Sutures (3/0 Undyed 30" PC-11 SV487G). The specific lot number is 20060814X, and the product was 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 surgery, increase the risk of a surgical site infection, and increase break strength retention.
Healthcare providers and facilities that have received this product should stop using it immediately. Consumers and patients who have had this specific suture used in a procedure should contact their healthcare provider for guidance.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" PC-11 SV487G, UDI: 10884521149595 - 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,
- Manufacturer
- Riverpoint Medical, LLC
- Affected units
- 1,236
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: 20060814X
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 →Related recalls
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