Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
FDA Recall Z-0949-2021 · Posted None
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Recalling FirmRiverpoint Medical, LLC
Recall StatusTerminated
Product CodeGAM
Date Initiated2020-12-09
Date Terminated2023-04-21
Product Quantity3060 units
Reason for Recall
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.
Firm Action
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 [email protected]. 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.
Root Cause
Process control
Distribution Pattern
US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain.
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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