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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiovascular Procedure Kit

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  Class 2 Device Recall Cardiovascular Procedure Kit see related information
Date Initiated by Firm May 12, 2017
Create Date July 26, 2018
Recall Status1 Terminated 3 on October 26, 2018
Recall Number Z-2550-2018
Recall Event ID 80283
Product Classification Cardiovascular procedure kit - Product Code OEZ
Product Tubing Pack Convenience Kit, Product Code 65217

Product Usage:
Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
Code Information Lot Number: VE17
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
28 Howe St
Ashland MA 01721-1305
For Additional Information Contact Garry A. Courtney, MBA, RAC
800-262-3304
Manufacturer Reason
for Recall		 Kit was labeled with the incorrect Expiration Date of April 30, 2019.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action On May 12, 2017 Terumo Cardiovascular Systems Corporation telephoned their one client and notified them of the labeling error and asked them to hold product. All product was immediately quarantined.
Quantity in Commerce 30 cases/2 units (Total 60 units)
Distribution US state of FL
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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