Reported Jun 26, 2019 · Ongoing
EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
Covidien LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien LLC · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
EGIA 30 ARTICULATING MED THICK SULUItem Code EGIA30AMT
- Lot codes and dates
- lots N5A0871KX N7A0527KX N7E0441KX N8J0039KX N8J0527KX N8J0820KX
- Amount recalled
- 3,113,280
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
Why it was recalled
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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