Reported Oct 7, 2020 · Ongoing
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA…
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 Articulating Loading Unit 45 mm - 3.5 mm
- Item Code 030455 - 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
68 of 68 codes
T0A019XT7K037XT8H021XT8L102XT9E097XT0A105XT7K038XT8H050XT8L103XT9E098XT0A117XT7K039XT8J044XT8M010XT9F025XT0A141XT7K040XT8J045XT9A037XT9F047XT0B132XT7K041XT8J060XT9A128XT9F048XT0C045XT7L040XT8K044XT9B002XT9F098XT0C102XT7L041XT8K045XT9B003XT9H112XT0C128XT8B042XT8K046XT9C065XT9H146XT0D057XT8B043XT8K052XT9C066XT9K003XT0D120XT8C032XT8K075XT9C111XT9L039XT7G002XT8C033XT8K076XT9C145XT9M029XT7H005XT8E059XT8K092XT9D140XT9M049X
- 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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