Reported Oct 7, 2020 · Ongoing
Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal…
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 Universal Loading Unit 45 mm - 2.5mm
- Item Code 030454 - 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
112 of 112 codes
T0A018XT8B045XT8E051XT8L052XT9E050XT0A106XT8B046XT8E052XT8L101XT9F024XT0B131XT8B047XT8E065XT8L131XT9F037XT0D138XT8C025XT8E066XT8L132XT9F040XT0E011XT8C030XT8H015XT8L143XT9F044XT7G001XT8C031XT8H016XT8M080XT9F045XT7H004XT8C043XT8H017XT8M092XT9F046XT7H007XT8D001XT8H018XT8M093XT9F097XT7J025XT8D002XT8H049XT8M094XT9G031XT7K018XT8D003XT8J012XT9A006XT9G124XT7K034XT8D004XT8J026XT9A034XT9G125XT7L022XT8D005XT8J039XT9A035XT9H041X
- 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.
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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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