Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling non-sterile Velosorb sutures because their use could compromise the sterile field and increase the 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 risk-of-harm product (non-sterile sutures) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical risk of surgical site infection.
Plain-English summary
Riverpoint Medical, LLC is recalling 9,820 units of Velosorb Fast Braided Absorbable Sutures, specifically the 3/0 Undyed 30" P-14 Cutting variety (Product Number: SV935, UDI: 20884521151755). The affected units are from Lot Number 20051215FX 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 sutures 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 intended for ligation, ophthalmic, cardiovascular, or neurological procedures.
Healthcare providers and facilities that have received this product should stop using it immediately and contact Riverpoint Medical for instructions on return or disposal. Consumers should not use this product for any medical procedure.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - 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 f
- Manufacturer
- Riverpoint Medical, LLC
- Hazard
- Affected units
- 9,820
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: 20051215FX
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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