FDAClass IIMay 1, 2019

Covidien Endo Grasp Auto Suture Grasper 5mm recall: Labeling Error

Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of…

Why was Covidien Endo Grasp Auto Suture Grasper 5mm recalled?

Sterilization method used was not consistent with the labeling and the approved sterilization method

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 Numbers: P8D1335PRX P8D1336PRX P8D1605PRX

Product
Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of…
Recalling firm
COVIDIEN LLC
Quantity
240 units
Distribution
Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
Recall date
May 1, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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