Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20884521152349 - 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, ophthalmic, cardiovascular or neurological procedures.
Reported: October 7, 2020 Initiated: August 3, 2020 #Z-0016-2021
Product Description
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20884521152349 - 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, ophthalmic, cardiovascular or neurological procedures.
Reason for Recall
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Details
- Recalling Firm
- Riverpoint Medical, LLC
- Units Affected
- 3110
- Distribution
- US Nationwide distribution.
- Location
- Portland, OR
Frequently Asked Questions
What product was recalled? ▼
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20884521152349 - 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, ophthalmic, cardiovascular or neurological procedures.. Recalled by Riverpoint Medical, LLC. Units affected: 3110.
Why was this product recalled? ▼
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 7, 2020. Severity: Moderate. Recall number: Z-0016-2021.
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