Reported Apr 21, 2021 · Terminated
Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
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 Grey Small Diameter Curved Tip Intelligent Reload 30
- mm Vascular 8 mm - Short Item CodeSIGSDS30CTV
- Lot codes and dates
- Lot Numbers
N0A0191UYN0D0392UYN0F0406UYN0L0708UYN0B0657UYN0E0133UYN0G0907UYN9K0376UYN0C0349UYN0E0956UYN0J0746UYN9K1093UYN0C0492UYN0E1026UYN0K0248UYN9L0796UYN0C1008UYN0F0202UYN0K0803UYN9M0418UYN0D0283UY
- N0F0221UY N0L0307UY N9M0651UY UDI10884521741881 20884521741888
- Lot Numbers
- Amount recalled
- 11391 units WW: 5982 US 5409 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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