Reported Jun 10, 2020 · Ongoing
Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has…
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?
- Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 -
- Product Usagehas application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s)
- Lot codes and dates
- Lots P9J0368Y P9J0369Y P9J0517Y P9K1300Y
- Amount recalled
- 12,610 total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.
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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