Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cutting, Product Number: SV496G, UDI: 20884521149691 - 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.
FDA Recall Z-0025-2021 · Posted None
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Recalling FirmRiverpoint Medical, LLC
Recall StatusTerminated
Product CodeGAM
Date Initiated2020-08-03
Date Terminated2022-09-08
Product Quantity1267
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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