Recall Z-0016-2021— Riverpoint Medical, LLC
Class II · Terminated
Class II FDA medical device recall by Riverpoint Medical, LLC, initiated 2020-08-03, terminated 2022-09-08. It names one FDA 510(k) clearance: K120556. Product: 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: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention..
- Recalling firm
- Riverpoint Medical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-03
- Terminated
- 2022-09-08
- Firm location
- Portland, OR, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.