Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 1,276 units of Velosorb Fast Braided Absorbable Sutures because the product is non-sterile. This condition 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 3/5 (High).
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 the hazard is theoretical and no injuries or illnesses have been reported in the source text, meeting the criteria for a High severity score.
Plain-English summary
Riverpoint Medical, LLC is recalling 1,276 units of Velosorb Fast Braided Absorbable Sutures (Product Number CV916, Lot Number 20060120X). The affected product is the Covidien Velosorb 3/0 Undyed 36" KV-34, TaperCutting 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 suture is non-sterile. The use of non-sterile sutures could compromise the sterile field, increase the risk of a surgical site infection, and increase break strength retention. The product was distributed nationwide in the United States.
Healthcare providers and facilities should stop using the affected sutures and contact Riverpoint Medical for further instructions. Consumers should not use this product for any medical procedure.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 36" KV-34, TaperCutting Product Number: CV916, UDI: 20884521153032 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required…
- Manufacturer
- Riverpoint Medical, LLC
- Hazard
- Affected units
- 1,276
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: 20060120X
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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