FDA recall Z-0010-2021

Riverpoint Medical, LLC · Class II · device

Product

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - 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.

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2020-08-03
Report date
2020-10-07
Termination date
2022-09-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portland, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0010-2021