Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdom...
FDA Recall #Z-0747-2021 — Class II — November 23, 2020
Product Description
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S
Reason for Recall
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
Recalling Firm
Covidien Llc — Mansfield, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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
Code Information
Lot Numbers: P0B1142MY, P0C1515MY, P0E0634MY, P0E1353MY, P0C0492MY,P0D1454MYP0E1352MY,P0G0601Y, P0C0493MY UDI: 10884521043145, 20884521043142
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.