Agency classClass IIOur severity:Severe FDA (Devices)·Z-0034-2021·Announced 2020-10-07

Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

Riverpoint Medical is recalling 1,811 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infection.

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. The hazard involves a non-sterile medical device used in surgical procedures, which presents a significant risk of surgical site infection and compromise of the sterile field, meeting the criteria for a Severe rating.

Plain-English summary

Riverpoint Medical, LLC is recalling 1,811 units of Velosorb Fast Braided Absorbable Sutures (Product Number: CV605, UDI: 20884521152295). The affected product is identified by Lot Number 20060201X and was distributed nationwide in the United States.

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 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 distributors should stop using the affected sutures immediately. Consumers who have purchased this product should contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI: 20884521152295 - 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…
Manufacturer: Riverpoint Medical, LLC
Category: Medical Device — Surgical Sutures
Hazard: infection
non-sterile
Affected units: 1,811

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: 20060201X

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 →

Same manufacturer · Riverpoint Medical, LLC

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Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures
FDA (Devices) · 2020-10-07
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Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures
FDA (Devices) · 2020-10-07
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Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
FDA (Devices) · 2020-10-07

Same hazard · infection