Reported Oct 7, 2020 · Ongoing
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The…
Covidien, LP
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, LP · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
- Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm
- Item Code 030450 - Product UsageThe Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis
- Lot codes and dates
- Lot Numbers
T0A108XT7H003XT8D008XT8K108XT9G060XT0E051XT7L023XT8H047XT8M079XT7G003XT8D007XT8K047XT9F132X
- Lot Numbers
- Amount recalled
- 900,007 total
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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