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Terminated

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper CV3110, UDI: 20884521150918 - 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-0047-2021 · Posted None

Recall StatusTerminated
Product CodeGAM
Date Initiated2020-08-03
Date Terminated2022-09-08
Product Quantity7982

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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