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Class 2 Device Recall Pinnacle Destination Guiding Sheath, 7 French, 90 cm |
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Date Initiated by Firm |
June 24, 2010 |
Date Posted |
June 06, 2011 |
Recall Status1 |
Terminated 3 on July 07, 2011 |
Recall Number |
Z-2416-2011 |
Recall Event ID |
58677 |
510(K)Number |
K052185
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Product Classification |
Introducer, catheter - Product Code DYB
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Product |
Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185
Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath. |
Code Information |
RSC02 |
Recalling Firm/ Manufacturer |
Terumo Medical Corporation 950 Elkton Blvd Elkton MD 21921-5322
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For Additional Information Contact |
Kathleen Little, PhD 410-392-7123
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Manufacturer Reason for Recall |
Molding defect in destination product that render the device unusable.
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FDA Determined Cause 2 |
Equipment maintenance |
Action |
Terumo Medical Corporation sent an Urgent Product Bulletin Recall letter dated June 24, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Terumo requested customers to immediately discontinue use, and quarantine any available stock of the listed product codes. In order to facilitate the exchange of these devices, a Terumo Territory Manager contacted all customers by July 9th to confirm receipt of the Terumo Destination Bulletin and scheduled an appointment to visit each customer in person by July 31st to personally manage the exchange. For questions or for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator. |
Quantity in Commerce |
37 units |
Distribution |
Worldwide Distribution - USA including AL, AK, AZ, TX, LA, MS, MN, MO, CA, GA, FL, HI, KS, IA, ID, IL, TN, NM, OR, OK, WA, and WI and the countries of Belgium, Brazil, and Panama |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = DYB and Original Applicant = TERUMO MEDICAL CORP.
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