Recall Z-2738-2016— Terumo Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Terumo Medical Corporation, initiated 2016-03-16, terminated 2017-01-27. It names one FDA 510(k) clearance: K111606. Product: PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath. Reason: 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..
- Recalling firm
- Terumo Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-16
- Terminated
- 2017-01-27
- Firm location
- Elkton, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.