Destination Renal Guiding Sheath Intended for the recall
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Why was Destination Renal Guiding Sheath Intended for the 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03
- Product
- Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
- Recalling firm
- Terumo Medical Corporation
- Quantity
- 5,252 eaches
- Distribution
- Nationwide Distribution.
- Recall date
- May 10, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)