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.
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510(K) Database | 510(K)s with Product Code = DYB
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