FDAClass IIMarch 3, 2021

Covidien Parietex hydrophilic anatomical mesh 15 cm x recall

Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via…

Why was Covidien Parietex hydrophilic anatomical mesh 15 cm x recalled?

incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is for right side use. Use of an opposite side mesh can result in implant failure and hernia recurrence

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 Number: SUH0709M

Product
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via…
Recalling firm
Covidien Llc
Quantity
129 units WW
Distribution
Worldwide distribution - US Nationwide distribution in the state of MA and the countries of France, French Guiana, Germany, Luxembourg, Spain, United Kingdom.
Recall date
March 3, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls