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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns MP4 Cardioplegia Sets

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  Class 2 Device Recall Sarns MP4 Cardioplegia Sets see related information
Date Initiated by Firm February 25, 2003
Date Posted March 20, 2003
Recall Status1 Terminated 3 on June 06, 2003
Recall Number Z-0664-03
Recall Event ID 25714
Product Classification Heat-Exchanger, Cardiopulmonary Bypass - Product Code DTR
Product Sarns MP4 Cardioplegia Sets; catalog number 15501.
Code Information Lot 322125
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
6200 Jackson Rd.
Ann Arbor MI 48103
For Additional Information Contact
800-521-2818
Manufacturer Reason
for Recall		 There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.
FDA Determined
Cause 2		 Other
Action Initial customers were notified by telephone beginning on February 25, 2003. A follow-up recall letter dated February 27, 2003 was sent to each customer. Wholesalers were requested to either contact their customers or to provide their customer information to Terumo so that Terumo could notify the customers.
Quantity in Commerce 300
Distribution United States
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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