Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling non-sterile Velosorb Fast Braided Absorbable Sutures due to a risk of surgical site infection.
What this means for you
Illness, injury, or structural failure has been reported. 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 hospitalization or significant injury).
Plain-English summary
Riverpoint Medical, LLC is recalling 10,457 units of Velosorb Fast Braided Absorbable Sutures (Lot 20061504FX) that were distributed nationwide in the United States. The specific product affected is the Covidien Velosorb 3/0 Undyed 30" P-14 Cutting suture, identified by UDI 20884521151755.
The recall was initiated because the surgical sutures are non-sterile. The use of these non-sterile sutures could compromise the sterile field during a procedure, which increases the risk of a surgical site infection. The source text also notes that the issue increases break strength retention.
This recall is classified as Class II by the FDA. Healthcare facilities and consumers who have this specific lot of sutures should stop using them and contact Riverpoint Medical for instructions on return or replacement.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting 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 for use in ligat
- Manufacturer
- Riverpoint Medical, LLC
- Hazard
- Affected units
- 10,457
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: 20061504FX
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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