FDAClass IIApril 30, 2014

Monodek Violet Synthetic Absorbable Surgical Sutures recall

Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48

Why was Monodek Violet Synthetic Absorbable Surgical Sutures recalled?

Product does not meet minimum knot tensile strength requirements.

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?

Product Code: 833-137, Batch: 02H1103434, 02H1200349, and 02K1201354.

Product
Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
Recalling firm
Teleflex Medical
Quantity
3,072 ea.
Distribution
Worldwide Distribution -- USA, including the state of MA, and the country of Germany
Recall date
April 30, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls