Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 1,256 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing 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 1,256 units of Velosorb Fast Braided Absorbable Sutures (Lot Number 20060204X). The affected product is the Covidien Velosorb 0 Undyed 36" GS-11 Cutting suture, identified by UDI 20884521151359. These sutures are 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, increase the risk of a surgical site infection, and increase break strength retention. The product was distributed nationwide in the United States.
This recall is classified as Class II by the FDA. Healthcare providers and facilities should stop using the affected sutures and contact Riverpoint Medical for instructions on return or disposal. Consumers are not directly affected as this is a professional medical device.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting CV4731, UDI: 20884521151359 - 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
- 1,256
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: 20060204X
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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