Date Initiated by Firm |
December 20, 2018 |
Create Date |
February 27, 2019 |
Recall Status1 |
Terminated 3 on August 20, 2019 |
Recall Number |
Z-0966-2019 |
Recall Event ID |
82019 |
Product Classification |
Cardiovascular procedure kit - Product Code OEZ
|
Product |
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222 |
Code Information |
Lot Numbers: V A30 |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 125 Blue Ball Rd Elkton MD 21921-5315
|
Manufacturer Reason for Recall |
Presence of natural rubber latex is not declared in the label
|
FDA Determined Cause 2 |
Component design/selection |
Action |
Terumo issued Urgent Medical Device Recall dated 12/20/18 stating reason for recall, health risk and an appropriate course of action for the return of affected product to Terumo. Questions or concerns:
Terumo CVS Customer Service: 1.800.521.2818 Monday ¿¿ Friday, 8 a.m. ¿¿ 6 p.m. ET. |
Quantity in Commerce |
12 packs |
Distribution |
TX |
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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