COVIDIEN MEDTRONIC: Medical Device Recall in 2018 - (Recall #: Z-2503-2018)
See the recall detail below. You can also see other recalls from the same firm in 2018.
Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT
Class II
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
N7L0521KX, N7M0047KX, N7M0592KX, N7M1001KX, N7L0975KX, N7M0434KX, N7M0683KX, N8A0203KX, N7L1057KX, N7M0528KX, N7M0937KX, N8A0677KX, N7L1098KX, N7M0529KX, N7M0949KX, N8C0144KX & N7L1099KX
Nationwide U.S.A. Internationally to: Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malta, Martinique, Moldova, Morocco, Namibia, Netherlands, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates & United Kingdom
Voluntary: Firm initiated