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U.S. Department of Health and Human Services

Class 2 Device Recall PINNACLE Introducer Sheath

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  Class 2 Device Recall PINNACLE Introducer Sheath see related information
Date Initiated by Firm March 16, 2016
Date Posted September 06, 2016
Recall Status1 Terminated 3 on January 27, 2017
Recall Number Z-2738-2016
Recall Event ID 73833
510(K)Number K111606  
Product Classification Introducer, catheter - Product Code DYB
Product PINNACLE¿ Introducer Sheath
PINNACLE PRECISION ACCESS SYSTEM¿ Sheath
PINNACLE¿ TIF TIP" Introducer Sheath
PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
Code Information Please see Attachment 3
Recalling Firm/
Manufacturer		 Terumo Medical Corporation
950 Elkton Blvd
Elkton MD 21921-5322
For Additional Information Contact
410-392-7226
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 1,370,995 eaches have been distributed to the field
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = TERUMO MEDICAL CORP.
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