Reported Dec 7, 2016 · Terminated
MISAGO RX Self Expanding Peripheral Stem
Terumo Medical Corp.
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: Terumo Medical Corp · 2101 Cottontail Ln · Somerset, NJ · 08873-1277
Is this the product you have?
- MISAGO RX Self Expanding Peripheral Stem
- Lot codes and dates
113 of 113 codes
150401150429150713150821150923151009160314150413150501150708150824150915151013151111150415150515150701150716150902151005151106150407150514150707150827151008151109160509150406150501150713150716150825151001151102160315160509150410150710150831150909151007151012151014151103151208150417150429150717150910151002151102160510150408150429150701150717150831151013151103
- Amount recalled
- 7,965 units
Where it was sold
- Nationwide
Why it was recalled
During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.
This product could cause temporary or reversible health problems — stop using it.
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