PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS recall
PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker…
Why was PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS recalled?
Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.
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?
Please see Attachment 3
- Product
- PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker…
- Recalling firm
- Terumo Medical Corporation
- Quantity
- 1,370,995 eaches have been distributed to the field
- Distribution
- Nationwide Distribution
- Recall date
- September 14, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)