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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 February 03, 2022
Create Date April 18, 2022
Recall Status1 Terminated 3 on February 20, 2024
Recall Number Z-0949-2022
Recall Event ID 89792
Product Classification Cardiovascular procedure kit - Product Code OEZ
Product Cardiovascular Procedure Kit catalog # 76645 & 73806
Code Information [Lot #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398, case label GTIN: (01)00699753477728, product identifier: (17)230228(10)Z16958398]
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
28 Howe St
Ashland MA 01721-1305
For Additional Information Contact Terumo Cardiovascular Systems (Terumo CVS) Customer Service
800-521-2818
Manufacturer Reason
for Recall		 Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
FDA Determined
Cause 2		 Under Investigation by firm
Action A customer notification letter was issued on 02/23/2022 by 2-day FedEx mailing advising customers to remove the affected product from use and return to Terumo CVS using the instructions provided.
Quantity in Commerce 64
Distribution US Nationwide distribution in the states of CA and IN.
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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