Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, UDI: 20884521151298 - 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.
This recall has been terminated (originally issued August 3, 2020).
- Company
- Riverpoint Medical, Llc
- Recall Initiated
- August 3, 2020
- Terminated
- September 8, 2022
- Recall Number
- Z-0036-2021
- Quantity
- 1272
- Firm Location
- Portland, OR
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot Number: 20060203X
Root Cause
Under Investigation by firm
Action Taken
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.