Z-2738-2016 Class II Terminated
FDA device recall Z-2738-2016 was initiated by Terumo Medical Corporation on March 16, 2016 and is designated Class II. Reason for recall: 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 increme… The recall status is terminated (terminated January 27, 2017). Affected quantity: 1,370,995 eaches have been distributed to the field.
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2016
- Initiation Date
- March 16, 2016
- Termination Date
- January 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,370,995 eaches have been distributed to the field
Product Description
PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution
Code Information
Please see Attachment 3