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
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 potential harm without confirmed illness.
Plain-English summary
Riverpoint Medical, LLC is recalling 1,264 units of Velosorb Fast Braided Absorbable Sutures (Product Number: CV486, UDI: 20884521150925). The affected product is identified by Lot Number 20052102X and was distributed nationwide in the United States.
The recall was initiated because the surgical sutures are non-sterile. The FDA notes that using these sutures could compromise the sterile field, increase the risk of a surgical site infection, and increase break strength retention. 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.
Healthcare facilities and consumers who have this specific lot of sutures should stop using them immediately and contact Riverpoint Medical for instructions on return or disposal.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-12, Cutting Product Number: CV486, UDI: 20884521150925 - 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
- Manufacturer
- Riverpoint Medical, LLC
- Hazard
- 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: 20052102X
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.
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