Recall Z-0949-2021— Riverpoint Medical, LLC
Class II · Terminated
Class II FDA medical device recall by Riverpoint Medical, LLC, initiated 2020-12-09, terminated 2023-04-21. It names one FDA 510(k) clearance: K120556. Product: Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307. 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..
- Recalling firm
- Riverpoint Medical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-09
- Terminated
- 2023-04-21
- Firm location
- Portland, OR, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.