Date Initiated by Firm |
August 03, 2020 |
Create Date |
October 01, 2020 |
Recall Status1 |
Terminated 3 on September 08, 2022 |
Recall Number |
Z-0014-2021 |
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 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - 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: 20051405FX |
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 |
5479 |
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
|