Reported Oct 7, 2020 · Ongoing
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - 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 30 mm - 3.5 mm
- Item Code 030452 - 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
T0C085XT8B048XT8K049XT8L087XT9J072XT7H002XT8B049XT8K095XT9G027XT9J099XT7L026XT8E063XT8L084XT9H043XT9L073XT7L027XT8E064XT8L085XT9H115XT9M016XT8B014XT8E075XT8L086XT9H116XT9M111XT8B015XT8F074X
- 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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