FDAClass IIJanuary 6, 2021

Covidien TA Auto Suture Vascular Stapler with DST recall

Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical…

Why was Covidien TA Auto Suture Vascular Stapler with DST recalled?

May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis

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: P0B1142MY, P0C1515MY, P0E0634MY, P0E1353MY, P0C0492MY,P0D1454MYP0E1352MY,P0G0601Y, P0C0493MY UDI: 10884521043145, 20884521043142

Product
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical…
Recalling firm
Covidien Llc
Quantity
3255 units US; 3574 units OUS
Distribution
Nationwide Foreign: Canada, Albania Armenia Australia Austria Belarus Belgium Bosnia And Herzegovina Cyprus Czech Republic Egypt Estonia France Germany Greece Hungary Iceland Israel Italy Japan Jordan Korea Kuwait Latvia Libyan Arab Jamahiriya Lithuania Malaysia Martinique Morocco Myanmar, Netherlands Norway Pakistan Poland Russian Federation Serbia Singapore Slovakia Spain Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom Viet Nam
Recall date
January 6, 2021
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls