FDAFDA · Food and drugs·Recall number Z-2033-2017
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Published May 10, 2017 · Recall initiated: November 6, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Terumo Medical Corporation
- Distributor
- Nationwide Distribution.
- Lot
- Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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