Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 1,222 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, which 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 medical device with a risk of surgical site infection, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Riverpoint Medical, LLC is recalling 1,222 units of Velosorb Fast Braided Absorbable Sutures (Lot Number 20060812X). The product is identified as Covidien Velosorb 0 Undyed 36" GS-25 CV604 with UDI 20884521152288. The recall was initiated because the surgical sutures are non-sterile.
The use of non-sterile sutures could compromise the sterile field during a procedure, increase the risk of a surgical site infection, and increase break strength retention. The product is indicated for use in soft tissue approximation of the skin and mucosa where only 7-10 days of wound support is required, but is not for use in ligation, ophthalmic, cardiovascular, or neurological procedures.
The affected units were distributed nationwide in the United States. Healthcare facilities and consumers should stop using the product and contact Riverpoint Medical for further instructions or a return.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-25 CV604, UDI: 20884521152288 - 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 ligation, op
- Manufacturer
- Riverpoint Medical, LLC
- Hazard
- Affected units
- 1,222
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: 20060812X
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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