Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling non-sterile Velosorb sutures that could compromise sterile fields and increase infection risk.
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 and involves a risk of surgical site infection, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
Riverpoint Medical, LLC is recalling 5,596 units of Velosorb Fast Braided Absorbable Sutures, specifically the 2/0 Undyed 30" V-20 Taper (Product Number CV417G, UDI 20884521149370). The affected units are identified by Lot Number 20051406X and were distributed nationwide in the United States.
The recall was initiated because the surgical sutures are non-sterile. The FDA notes that using these products 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 should stop using the affected sutures immediately. Riverpoint Medical is responsible for managing the recall and notifying affected customers.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-20 Taper, Product Number: CV417G, UDI: 20884521149370 - 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
- Affected units
- 5,596
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: 20051406X
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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Same hazard · surgical site infection
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