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Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/...

FDA Recall #Z-0949-2021 — Class II — December 9, 2020

Recall #Z-0949-2021 Date: December 9, 2020 Classification: Class II Status: Terminated

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.

Recalling Firm

Riverpoint Medical, LLC — Portland, OR

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

3060 units

Distribution

US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain.

Code Information

Lot # 19062715X

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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