Reported May 10, 2017 · Terminated
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human…
Terumo Medical Corporation
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 Corporation · 950 Elkton Blvd · Elkton, MD · 21921-5322
Is this the product you have?
- Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
- Lot codes and dates
- Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03
- Amount recalled
- 5,252 eaches
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.
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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