Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 1,253 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. This defect could compromise the sterile field and increase the risk of surgical site infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. The hazard involves a non-sterile medical device used in surgery, which poses a significant risk of surgical site infection, meeting the criteria for a Severe rating.
Plain-English summary
Riverpoint Medical, LLC is recalling 1,253 units of Velosorb Fast Braided Absorbable Sutures, specifically the 2/0 Undyed 30" GS-20 CV9975G model (Lot Number: 20060930X). The product was distributed nationwide in the United States. The recall was initiated because the surgical sutures are non-sterile.
The use of non-sterile sutures could compromise the sterile field during surgery. This defect increases the risk of a surgical site infection and may affect break strength retention. The sutures are indicated for soft tissue approximation of the skin and mucosa where 7-10 days of wound support is required, but are not for use in ligation, ophthalmic, cardiovascular, or neurological procedures.
Healthcare providers and facilities that have received this product should stop using it immediately. They should contact Riverpoint Medical, LLC for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G, UDI: 20884521149585 - 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
- Hazard
- Affected units
- 1,253
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: 20060930X
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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