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U.S. Department of Health and Human Services

Class 2 Device Recall Destination Renal Guiding Sheath Catheter introducer/Guiding Sheath

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  Class 2 Device Recall Destination Renal Guiding Sheath Catheter introducer/Guiding Sheath see related information
Date Initiated by Firm November 06, 2015
Date Posted May 04, 2017
Recall Status1 Terminated 3 on May 12, 2017
Recall Number Z-2033-2017
Recall Event ID 76939
510(K)Number K012854  
Product Classification Introducer, catheter - Product Code DYB
Product Destination Renal Guiding Sheath

Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Code Information Terumo Product Code - RSR01  Affected Lot Numbers  RN19  RN26  RP03
Recalling Firm/
Manufacturer		 Terumo Medical Corporation
950 Elkton Blvd
Elkton MD 21921-5322
For Additional Information Contact
410-392-7226
Manufacturer Reason
for Recall		 Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.
FDA Determined
Cause 2		 Other
Action An Urgent Product Bulletin Recall of Terumo Medical Product letter, dated November 6, 2015, was sent to customers. The letter identified the affected product and the reason for the voluntary recall. The letter asked customers to immediately discontinue use and quarantine any of the affected product listed. Customers are to complete the enclosed Contact & Inventory Confirmation Form and e-mail DSRenalRecall@terumomedical.com or fax to 732-412-4121, Attn: Destination Recall. For questions or further information, customers can contact Customer Care at 800-888-3786 or their local sales representative.
Quantity in Commerce 5,252 eaches
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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