Reported Oct 10, 2018 · Terminated
EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage:…
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 · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
- EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT
- TRIEEA31MT TRIEEA31XT Product UsageThe EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis
- Lot codes and dates
P8A0976XP8A0977XP8A0978XP8A0979XP8A0980XP8A0981XP8B1538XP8B1539XP8B1540XP8B1541XP8B1542XP8C0032XP8C0033XP8C1177XP8C1178XP8C1179XP8C1180XP8C1181XP8C1183XP8D1405XP8D1406XP8D1407XP8D1408XP8D1409XP8D1410XP8D1411XP8E1211XP8E1212XP8E1213XP8E1214XP8E1215XP8E1216XP8E1217XP8E1304XP8E1305X
- Amount recalled
- 1,902
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.
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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