Reported Apr 21, 2021 · Terminated
Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
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?
- Covidien Signia Small Diameter Curved Tip Intelligent Reload 45
- mm Vascular/Thin 8 mm - Long Item CodeSIGSDL45CTVT
- Lot codes and dates
- Lot Numbers
N0A1038UYN0E0016UYN0F0616UYN0K0934UYN0B0493UYN0F0254UYN0F0817UYN0M0334UYN0C0436UYN0F0518UYN0G0388UYN9K1095UYN0D0731UY
- N0F0615UY N0J0859UY N9L0797UY UDI10884521741843 20884521741840
- Lot Numbers
- Amount recalled
- 5928 units WW: 4212 US 1716 OUS
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.
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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