PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath PINNACLE R/O II Radiopaque Marker Introducer Sheath
This recall has been terminated (originally issued September 6, 2016).
- Company
- Terumo Medical Corporation
- Recall Initiated
- March 16, 2016
- Posted
- September 6, 2016
- Terminated
- January 27, 2017
- Recall Number
- Z-2738-2016
- Quantity
- 1,370,995 eaches have been distributed to the field
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
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
Nationwide Distribution
Lot / Code Info
Please see Attachment 3
Root Cause
Device Design
Action Taken
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 need assistance procuring additional inventory. We are committed to continuing to offer products that meet the highest quality standards that you expect from Terumo Medical Corporation. If you have questions or need further information, please call Customer Care at 1-800-888-3786 or contact your local sales representative. For further questions regarding this recall please call (410) 392-7226.