Riverpoint Medical, LLC Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence.

Recommended Action

Per FDA guidance

On 12/11/2020, Riverpoint Medical issued a "Urgent: Medical Device Recall" notification via Email to affected consignees. In addition to informing consignees about the recall, Riverpoint asked consignees to take the following actions: 1. Immediately examine your inventory and quarantine product subject to the recall. 2. Discontinue selling product listed above (lot 19062715X) and return any existing stock to Riverpoint Medical. 3. Complete and return the enclosed response form as soon as possible to quality@rpmed.com. Mark the return shipments with RGA#12072020MDT 4. Provide recall information to any customers to whom you may have distributed or forwarded affected product. You may include a copy of this recall notice with your customer notification. 5. If you have any questions, call Riverpoint Medical at (503) 517-8001.

Distribution

As reported by FDA

NJ