FDAClass IIFebruary 26, 2020

Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET recall: Sterility Concern

Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201

Why was Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET recalled?

There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

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 - D7H0404X Expiration Date - 2022-08-31

Product
Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
Recalling firm
Covidien LLC
Quantity
139,938 units total
Distribution
US Nationwide distribution.
Recall date
February 26, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls