Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Velosorb Fast Braided Absorbable Suture

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Velosorb Fast Braided Absorbable Suture see related information
Date Initiated by Firm August 03, 2020
Create Date October 01, 2020
Recall Status1 Terminated 3 on September 08, 2022
Recall Number Z-0048-2021
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 3/0 Undyed 30" P-14 Cutting SV935, UDI: 20884521151755 - 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:  20061504FX 
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 2		 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 10457
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 and Original Applicant = RIVERPOINT MEDICAL
-
-