Class 2 Device Recall Velosorb Fast Braided Absorbable Suture

• Date Initiated by Firm: August 03, 2020
• Create Date: October 01, 2020
• Recall Status: Terminated on September 08, 2022
• Recall Number: Z-0031-2021
• Recall Event ID: 86254
• 510(K)Number: K120556
• Product Classification: Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
• Product: Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, Product Number: CV2293, UDI: 20884521151588 - 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.
• Code Information: Lot Number: 20060118X
• Recalling Firm/ Manufacturer: Riverpoint Medical, LLC; 825 NE 25th Ave; Portland OR 97232-2304
• For Additional Information Contact: Doug King; 503-517-8001
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On 08/03/2020, the firm notified affected customer via email using a letter titled, "URGENT: MEDICAL DEVICE RECALL" indicating that the customer should do the following: - Immediately examine inventory and quarantine product subject to the recall. - Discontinue selling product listed above and return any existing stock to the firm. - Complete and return the enclosed response form as soon as possible via email. Mark the return shipments with the RGA number. - Provide recall information to any customers to whom you may have distributed or forwarded affected product. Customer may include a copy of this recall notice with your customer notification. If you have any questions, call the firm at (503) 517-8001.
• Quantity in Commerce: 1264
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GAM