Recall Z-2738-2016 ยท DYB Introducer, Catheter
Terumo Medical Corporation
PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath PINNACLE R/O II Radiopaque Marker Introducer Sheath
| Date | Sep 6, 2016 (initiated Mar 16, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Terumo sent an Urgent Product Recall Bulletin dated March 7, 2016, to all affected customers. All affected customers will be notified regarding the required recall actions (stop using/quarantine the affected products). TMC will strive for 100% verification to confirm that all customers have acknowledged the recall. Follow-up communication is being sent specifying the mechanisms to be used for labeling and returning the involved product from the customer level. We regret any inconvenience this action may cause your operations and we appreciate your understanding. Please contact us if you ne |
| Quantity | 1,370,995 eaches have been distributed to the field |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111606 | PINNACLE PRECISION ACCESS SYSTEM Terumo Medical Corp., Oct 3, 2011 |