Device Recall PINNACLE Introducer Sheath 의 리콜

Recall

73833

Class 2

Z-2738-2016

2016-03-16

2016-09-06

Terminated

United States

2017-01-27

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145071

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.

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.