FDAClass IIFebruary 10, 2021

Covidien CV-9590 Velosorb Fast Braided Fast absorbable recall

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

Why was Covidien CV-9590 Velosorb Fast Braided Fast absorbable recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 19062715X

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
Recalling firm
Riverpoint Medical, LLC
Quantity
3060 units
Distribution
US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain.
Recall date
February 10, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls