Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 1,268 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The 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 agency classified this as a Class II recall. The hazard involves a non-sterile medical device used in surgical procedures, which poses a significant risk of surgical site infection and compromise of the sterile field, meeting the criteria for a Severe rating.
Plain-English summary
Riverpoint Medical, LLC is recalling 1,268 units of Velosorb Fast Braided Absorbable Sutures (Product Number: SV835G, Lot Number: 20060119X). The affected product is the Covidien Velosorb 4/0 Undyed 18" PC-10 suture, which is indicated for soft tissue approximation of the skin and mucosa where 7-10 days of wound support is required.
The recall was initiated 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 was distributed nationwide in the United States.
Healthcare facilities and consumers should stop using the affected sutures immediately. Riverpoint Medical is responsible for the recall and will manage the return or disposal of the product.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product Number: SV835G, UDI: 20884521149721 - 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…
- Manufacturer
- Riverpoint Medical, LLC
- Hazard
- Affected units
- 1,268
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: 20060119X
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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