FDAClass IIApril 17, 2013

Covidien Endo GIA AutoSuture Universal Loading Unit recall

Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic…

Why was Covidien Endo GIA AutoSuture Universal Loading Unit recalled?

Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention

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 Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.

Product
Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic…
Recalling firm
Covidien LP
Quantity
6,751 units
Distribution
Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.
Recall date
April 17, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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