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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Cardiovascular Systems

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 Class 2 Device Recall Terumo Cardiovascular Systemssee related information
Date Initiated by FirmDecember 20, 2018
Create DateFebruary 27, 2019
Recall Status1 Terminated 3 on August 20, 2019
Recall NumberZ-0966-2019
Recall Event ID 82019
Product Classification Cardiovascular procedure kit - Product Code OEZ
ProductCardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Code Information Lot Numbers: V A30
FEI Number 3000204839
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
ActionTerumo 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 Commerce12 packs
DistributionTX
Total Product Life CycleTPLC 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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