PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath PINNACLE R/O II R

FDA device recall Z-2738-2016 · posted 2016-09-06 · Terminated

Recall details

Recalling firm

Terumo Medical Corporation

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.

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.

Root cause

Device Design

Status

Terminated

Product code

DYB

Quantity affected

1,370,995 eaches have been distributed to the field

Distribution

Nationwide Distribution

Date initiated

2016-03-16

Date posted

2016-09-06

Date terminated

2017-01-27

Location

Elkton, MD

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