FDAFDA · Food and drugs·Recall number Z-2503-2018
Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT
Published July 25, 2018 · Recall initiated: May 22, 2018
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- COVIDIEN MEDTRONIC
- Distributor
- 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
- Lot
- N7L0521KX, N7M0047KX, N7M0592KX, N7M1001KX, N7L0975KX, N7M0434KX, N7M0683KX, N8A0203KX, N7L1057KX, N7M0528KX, N7M0937KX, N8A0677KX, N7L1098KX, N7M0529KX, N7M0949KX, N8C0144KX & N7L1099KX
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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