Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 7,982 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 medical device with a risk of harm (surgical site infection) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Riverpoint Medical, LLC is recalling 7,982 units of Velosorb Fast Braided Absorbable Sutures (Lot Number 20061108X). The affected product is the Covidien Velosorb 3/0 Undyed 30" CV-25 Taper CV3110, identified by UDI 20884521150918. This suture is indicated for soft tissue approximation of the skin and mucosa where 7-10 days of wound support is required, but is not intended for ligation, ophthalmic, cardiovascular, or neurological procedures.
The recall was initiated because the surgical sutures are non-sterile. The use of non-sterile sutures could compromise the sterile field during surgery, thereby increasing the risk of a surgical site infection. The source text also notes an increase in break strength retention.
The product was distributed nationwide in the United States. Healthcare facilities and consumers who have this specific lot of sutures should stop using them immediately and contact Riverpoint Medical for further instructions.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper CV3110, UDI: 20884521150918 - 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 ligat
- Manufacturer
- Riverpoint Medical, LLC
- Hazard
- Affected units
- 7,982
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: 20061108X
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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