Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - 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.
Recall
- Recall Number
- Z-0013-2021
- Event Number
- 86254
- Firm
- Riverpoint Medical, LLC
- FEI Number
- 3006981798
- Product Code
- GAM
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- August 3, 2020
- Terminated
- September 8, 2022
- Address
- 825 NE 25th Ave, Portland, OR, 97232-2304
Description
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - 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.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
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.
US Nationwide distribution.
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