Riverpoint Medical, LLC Recall 87036
Description: Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
Riverpoint Medical, LLC Recall 87036 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0949-2021 |
| Event ID | 87036 |
| Event Description | Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307 |
| Product Type | Devices |
| Distribution | US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain. |
| Quantity | 3060 units |
| Recall Reason | 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. |
| Device Classification | 20210210 |
| Device Code Info | Lot # 19062715X |
| Center Classification Date | 20210203 |
| Recall Initiation Date | 20201209 |
| Recalling Firm | Riverpoint Medical, LLC |
| Initial Notification | Letter |
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