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U.S. Department of Health and Human Services

Class 2 Device Recall Pinnacle Destination Guiding Sheath, 7 French, 90 cm

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 Class 2 Recall
Pinnacle Destination Guiding Sheath, 7 French, 90 cm
see related information
Date Posted June 06, 2011
Recall Status1 Terminated on July 07, 2011
Recall Number Z-2416-2011
Recall Event ID 58677
Premarket Notification
510(K) Number
K012854 
Product Classification Introducer, Catheter - Product Code DYB
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, Maryland 21921-5322
For Additional Information Contact Kathleen Little, PhD
410-392-7123
Manufacturer Reason
for Recall
Molding defect in destination product that render the device unusable.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = TERUMO MEDICAL CORP.
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