Reported Jul 17, 2019 · Terminated
MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009…
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?
- MAHURKAR and Argyle acute hemodialysis catheters, Material numbers
122 of 122 codes
881379300988137930138813794005881379400988138160058813816009881381700588138170098815668007881566801188156680218815668027881714200588171430058817145005881714600188171460078817149007881723201888172320198817277007881727701188172770218817277027883041400188304140028830415001883041500388304160018830416003883041602188304160238831173010883117301188311730128831661001883166200188316630018831663002883166302188316630228832539001883253900288325390038832539006883253900788881151328888115133888811516288881151638888115192888811519388881152428888115243888813513188881351328888135133888813513488881351358888135136
- Lot codes and dates
- All lots
- Amount recalled
- 2,223,067
Where it was sold
- Nationwide
Why it was recalled
The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
This product could cause temporary or reversible health problems — stop using it.
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